Aging, Perioral Rhytids, Wrinkle
Conditions
Keywords
Perioral rhytids, Dermal filler, Hyaluronic acid, Aging, Wrinkle
Brief summary
Randomized, blinded, No-Treatment control, multi-center, prospective clinical study, to identify whether TEOSYAL RHA® Redensity is more effective than No-Treatment in the correction of moderate to severe dynamic perioral rhytids at Week 8 after last treatment (i.e., initial or touch-up treatment). The Treating Investigator (TI) at screening will evaluate the subject's perioral rhytids severity using the Perioral Rhytids Severity Rating Scale (PR-SRS) for eligibility of the subject for the study. The Blinded Live Evaluator (BLE) at screening will evaluate the subject's perioral rhytids severity using the PR-SRS in order to confirm eligibility and to establish a pre-treatment (Baseline) score for assessment of effectiveness. This is done independently of the TI, and exact concordance between the BLE and the TI is not necessary for eligibility of the subject in this study. Enrolled subjects will be randomized to either the TEOSYAL RHA® Redensity treatment group or the No-Treatment control group (ratio 3:1). The TI will administrate the study device, and if necessary, subjects will receive a touch-up treatment 14 days following the initial treatment to optimize the results. The TI will conduct safety and effectiveness evaluations at study visits, which occurred at Week 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. The Blinded Live Evaluator (BLE) will conduct assessments of effectiveness during the trial, including assessment of the primary endpoint at Week 8 after the last treatment (i.e., initial or touch-up treatment). The BLE will conduct effectiveness evaluations at Week 8, 12, 16, 24, 36, and 52 after the last treatment (i.e., initial or touch-up treatment). All subjects will be followed for 52 weeks after the last treatment (i.e., initial treatment or touch-up), at which point they will be offered Repeat-Treatment (provided that the TI deems the treatment to be appropriate and the subject agrees) and will be then followed for 4 weeks after Repeat-Treatment before exiting the study. If a subject returns to his pre-treatment PR-SRS score at Week 12 or Week 16 or Week 24 or Week 36 after initial treatment or touch up (as assessed by the TI), subjects are eligible for optional Early-Retreatment if necessary at 12 or 16 or 24 or 36 weeks after last treatment (provided that the TI deems the treatment appropriate, and the subject agrees). Subjects will be then followed for an additional 4 weeks after Repeat-Treatment. Subjects who will receive optional Early-Retreatment at Week 12 or Week 16 or Week 24 or Week 36 after the after initial treatment or touch-up, will be offered Repeat-Treatment at Week 52. Subjects randomized to the No-Treatment control group will receive their first treatment after the primary endpoint evaluation (Week 8 after randomization) and then will be followed the same schedule as the initial treatment group.
Interventions
DEVICETEOSYAL RHA Redensity
A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
Sponsors
Teoxane SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Outpatient, male or female of any race, 22 years of age or older * Moderate to severe perioral rhytids of grade 2 or 3 on the four-point PR-SRS (ranging from 0-3) * Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations * Able to follow study instructions and complete all required visits. * Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.
Exclusion criteria
: * Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control * Known hypersensitivity/allergy to any component of the study devices * Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders * Clinically significant active skin disease within 6 months * History of connective tissue disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Week 8 after last treatment | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Weeks 4 and 8 after last treatment | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. |
| Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Week 8 after last treatment | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. |
| Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Week 8 after last treatment | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was not pooled for this secondary outcome measure. |
| Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline through Week 52 following the last treatment and 4 weeks following re-treatment | The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 52 or to 1 month following the last treatment. |
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Baseline, Weeks 4 and 8 after last treatment | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome and adapted to a 100- unit scale. The No-Treatment control group after treatment was not pooled for this secondary outcome measure. |
| Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline, Weeks 2, 12, 16, 24, 36 and 52 | The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS). VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain. |
| Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. |
| Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment. | This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. |
| Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | During 14 days after initial treatment and touch-up (2 weeks) | The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captures the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other. The 14-day patient CTR diary includes a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate other if the subject experienced a sign/symptom that is not listed. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
| Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Weeks 4 and 8 after last treatment | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 4 - Baseline score) and (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. |
| Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment | The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
| Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment | The natural look and feel of the perioral area was assessed by subjects using an 11-point scale (ranging from 0 to 10). The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
| Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
| Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Weeks 4 and 8 after last treatment | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Week 8 after last treatment | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score). |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Weeks 4 and 8 after last treatment | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score) and (Week 8 - Baseline score) |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) |
| Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment | The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). For a given subject to be considered a responder, at least 2 of the 3 readers must have confirmed a 1-point improvement for that subject The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Weeks 8, 12, 16, 24, 36 and 52 after last treatment | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) |
| Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment | The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) |
| Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment | The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q (Perioral Rhytids Domain) score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 202 subjects were randomized with 150 subjects allocated to TEOSYAL RHA® Redensity and 52 subjects allocated to No-Treatment control.
Participants by arm
| Arm | Count |
|---|---|
| TEOSYAL RHA Redensity Injection of TEOSYAL RHA Redensity into the perioral lines. Up to 6.0 mL (max 3 mL for upper and max 3 mL for lower) injected into the dermis, including the superficial dermis. Touch-up treatment provided at 2 weeks (up to 6.0 mL).
TEOSYAL RHA Redensity: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G ½ inch disposable sterile needles. | 150 |
| No Treatment No treatment control group | 51 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 7 | 4 |
Baseline characteristics
| Characteristic | No Treatment | Total | TEOSYAL RHA Redensity |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 7.6 | 61.4 years STANDARD_DEVIATION 7.3 | 61.6 years STANDARD_DEVIATION 7.2 |
| Alcohol History Alcohol currently : No | 8 Participants | 46 Participants | 38 Participants |
| Alcohol History Alcohol currently : Yes, ≤1 drink per day | 40 Participants | 141 Participants | 101 Participants |
| Alcohol History Alcohol currently : Yes, ≥ 1 drink per day | 2 Participants | 5 Participants | 3 Participants |
| Alcohol History Alcohol past 5 yrs : No | 7 Participants | 43 Participants | 36 Participants |
| Alcohol History Alcohol past 5 yrs : Yes | 43 Participants | 150 Participants | 107 Participants |
| BMI | 24.8 kg/m^2 STANDARD_DEVIATION 4.9 | 25.1 kg/m^2 STANDARD_DEVIATION 4.7 | 25.3 kg/m^2 STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 35 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 166 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Type I - III | 36 Participants | 146 Participants | 110 Participants |
| Fitzpatrick Skin Type Type IV - VI | 15 Participants | 55 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 194 Participants | 143 Participants |
| Region of Enrollment Canada | 9 participants | 39 participants | 29 participants |
| Region of Enrollment United States | 42 participants | 163 participants | 121 participants |
| Sex: Female, Male Female | 50 Participants | 197 Participants | 147 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
| Smoking History Smoke currently - No | 45 Participants | 168 Participants | 123 Participants |
| Smoking History Smoke currently - Yes, ≤1 pack equivalents/day | 4 Participants | 24 Participants | 20 Participants |
| Smoking History Smoke currently - Yes, ≥1 pack equivalents/day | 1 Participants | 1 Participants | 0 Participants |
| Smoking History Smoke past 5 yrs - No | 41 Participants | 161 Participants | 120 Participants |
| Smoking History Smoke past 5 yrs - Yes | 9 Participants | 32 Participants | 23 Participants |
| Sun Exposure Artificial Tanning : ≤1per session/month | 4 Participants | 15 Participants | 11 Participants |
| Sun Exposure Artificial Tanning : ≥1 per session/month | 3 Participants | 3 Participants | 0 Participants |
| Sun Exposure Artificial Tanning : None | 43 Participants | 174 Participants | 131 Participants |
| Sun Exposure Protects face : Always | 26 Participants | 90 Participants | 64 Participants |
| Sun Exposure Protects face : Never | 2 Participants | 8 Participants | 6 Participants |
| Sun Exposure Protects face : Sometimes | 12 Participants | 43 Participants | 31 Participants |
| Sun Exposure Protects face : Usually | 10 Participants | 52 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 49 | 0 / 151 |
| other Total, other adverse events | 120 / 200 | 7 / 49 | 74 / 151 |
| serious Total, serious adverse events | 7 / 200 | 0 / 49 | 1 / 151 |
Outcome results
Primary
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this primary outcome measure.
Time frame: Week 8 after last treatment
Population: The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Responder | 121 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Not Responder | 29 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Not Responder | 47 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Responder | 4 Participants |
p-value: 0.0001Fisher Exact
Secondary
Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity.
The Injection Site Pain (during injection and post-injection) will be self-assessed by the subject using a 100 mm Visual Analog Scale (VAS). VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain.
Time frame: Baseline, Weeks 2, 12, 16, 24, 36 and 52
Population: All numbers are based on the total number of subjects where the data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline VAS pain score during injection | 19.9 score on a scale | Standard Deviation 19.7 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline VAS pain score 15 minutes after | 3.1 score on a scale | Standard Deviation 8.3 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 VAS pain score during injection | 25.4 score on a scale | Standard Deviation 23.3 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 VAS pain score 15 minutes after | 4.4 score on a scale | Standard Deviation 10.1 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 VAS pain score during injection | 14.3 score on a scale | Standard Deviation 10.8 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 VAS pain score 15 minutes after | 2.0 score on a scale | Standard Deviation 4.9 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 VAS pain score during injection | 25.0 score on a scale | Standard Deviation 20.2 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 VAS pain score 15 minutes after | 0.8 score on a scale | Standard Deviation 1.5 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 VAS pain score during injection | 24.8 score on a scale | Standard Deviation 28.3 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 VAS pain score 15 minutes after | 2.7 score on a scale | Standard Deviation 6.3 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 VAS pain score during injection | 40.6 score on a scale | Standard Deviation 23.6 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 VAS pain score 15 minutes after | 5.6 score on a scale | Standard Deviation 6.2 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 VAS pain score during injection | 19.7 score on a scale | Standard Deviation 21.9 |
| TEOSYAL RHA Redensity | Assessment of Injection Site Pain Felt by the Patient for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 VAS pain score 15 minutes after | 3.6 score on a scale | Standard Deviation 10.8 |
Secondary
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Population: The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment), in order to confounding recovery with the effect of the new injection cycle(s).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - pre-injection | Able to use straw | 199 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - pre-injection | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - post-injection | Able to use straw | 176 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - post-injection | Not able to use straw | 24 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - pre-injection | Able to use straw | 198 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - pre-injection | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - post-injection | Able to use straw | 127 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - post-injection | Not able to use straw | 11 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 4 | Able to use straw | 195 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 4 | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 8 | Able to use straw | 197 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 8 | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 | Able to use straw | 179 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 | Able to use straw | 180 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 | Able to use straw | 182 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 | Able to use straw | 173 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 | Not able to use straw | 0 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 | Able to use straw | 46 Participants |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 | Not able to use straw | 0 Participants |
Secondary
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment. Lip sensation
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Population: The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment) in order to confounding recovery with the effect of the new injection cycle(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - pre-injection | 99.9 Proportion of touchpoints with sensation | Standard Deviation 1.2 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - post-injection | 81.9 Proportion of touchpoints with sensation | Standard Deviation 35.4 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - pre-injection | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - post-injection | 86.7 Proportion of touchpoints with sensation | Standard Deviation 31.9 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 4 | 99.9 Proportion of touchpoints with sensation | Standard Deviation 1.19 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 8 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 | 99.9 Proportion of touchpoints with sensation | Standard Deviation 1.25 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
Secondary
Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Population: The following results reports data from subjects who received only the initial treatment (and if applicable, touch-up treatment) in order to confounding recovery with the effect of the new injection cycle(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - pre-injection | 99.8 Proportion of touchpoints with sensation | Standard Deviation 2.4 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - post-injection | 80.3 Proportion of touchpoints with sensation | Standard Deviation 36 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - pre-injection | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - post-injection | 86.4 Proportion of touchpoints with sensation | Standard Deviation 32.11 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 4 | 99.9 Proportion of touchpoints with sensation | Standard Deviation 1.19 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 8 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 | 99.9 Proportion of touchpoints with sensation | Standard Deviation 1.3 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 | 100.0 Proportion of touchpoints with sensation | Standard Deviation 0 |
Secondary
Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity.
This Lip functionality testing was conducted by the Treating Investigator (TI) at each follow-up visit and pre- and post-injection at each injection, which occurred at Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 36, and 52 after the last treatment, (i.e., initial or touch-up treatment) and 4 weeks after a Repeat-Treatment.
Population: All percentages are based on the total number of subjects where the data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - pre-injection | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Baseline - post-injection | 87.0 Proportion of words pronounced correctly | Standard Deviation 32.6 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - pre-injection | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 2 - post-injection | 91.7 Proportion of words pronounced correctly | Standard Deviation 27.2 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 4 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 8 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 12 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 16 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 24 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 36 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
| TEOSYAL RHA Redensity | Assessments of the Lip Function (Lip Movement) by the Treating Investigator (TI) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Week 52 | 100.0 Proportion of words pronounced correctly | Standard Deviation 0 |
Secondary
Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity.
The Treating Investigator will assess adverse events and record details of seriousness, severity, duration, and action taken with the study device, and relationship to the study device. AEs will be reported from the time of consent until week 52 or to 1 month following the last treatment.
Time frame: Baseline through Week 52 following the last treatment and 4 weeks following re-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | Any Serious Adverse Event | 7 Participants |
| TEOSYAL RHA Redensity | Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | Any Treatment Emergent Adverse Event | 120 Participants |
| TEOSYAL RHA Redensity | Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | Any Treatment Related Adverse Event | 73 Participants |
| TEOSYAL RHA Redensity | Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | Any Treatment Related Serious Adverse Event | 0 Participants |
| TEOSYAL RHA Redensity | Number of Participants With Adverse Events for the Safety Evaluation of TEOSYAL RHA® Redensity. | Any Unexpected Adverse Device Effects | 0 Participants |
Secondary
Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity.
The subjects will receive a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after treatment. The diary will be discussed during telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm). The subject diary captures the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other. The 14-day patient CTR diary includes a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate other if the subject experienced a sign/symptom that is not listed. The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR).
Time frame: During 14 days after initial treatment and touch-up (2 weeks)
Population: All numbers are based on the number of total number of subjects who provided diary answers after their treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Redness | 131 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Pain | 54 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Tenderness | 105 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Firmess | 115 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Swelling | 146 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Lumps/Bumps | 115 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Bruising | 154 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Itching | 31 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Initial Treatment : Discoloration | 94 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Redness | 85 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Pain | 29 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Tenderness | 54 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Firmess | 57 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Swelling | 84 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Lumps/Bumps | 59 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Bruising | 82 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Itching | 11 number of subjects |
| TEOSYAL RHA Redensity | Number of Post-Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for the Safety Evaluation of TEOSYAL RHA® Redensity. | Touch-up Treatment : Discoloration | 39 number of subjects |
Secondary
Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment.
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Time frame: Week 8 after last treatment
Population: The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Satisfied | 133 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Not Satisfied | 14 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Missing values | 3 Participants |
| No Treatment | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Satisfied | 4 Participants |
| No Treatment | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Not Satisfied | 39 Participants |
| No Treatment | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Week 8 After Last Treatment. | Missing values | 8 Participants |
Secondary
Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Time frame: Week 8 after last treatment
Population: The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Improved | 135 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | No Improvement | 11 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Missing values | 4 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Improved | 4 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | No Improvement | 44 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Missing values | 3 Participants |
Secondary
Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Time frame: Weeks 4 and 8 after last treatment
Population: The Intent-to-Treat Population (n=150 for the Teosyal RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 4 | Improved | 144 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 4 | No Improvement | 2 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 4 | Missing values | 4 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 8 | Improved | 141 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 8 | No Improvement | 6 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 8 | Missing values | 3 Participants |
| No Treatment | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 8 | No Improvement | 49 Participants |
| No Treatment | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 4 | Improved | 1 Participants |
| No Treatment | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 8 | Improved | 0 Participants |
| No Treatment | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 4 | No Improvement | 46 Participants |
| No Treatment | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 8 | Missing values | 2 Participants |
| No Treatment | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Week 8 and 4 After Last Treatment. | Week 4 | Missing values | 4 Participants |
Secondary
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior outcome and adapted to a 100- unit scale. The No-Treatment control group after treatment was not pooled for this secondary outcome measure.
Time frame: Baseline, Weeks 4 and 8 after last treatment
Population: The Intent-to-Treat Population (n=150 for the TEOSYAL RHA Redensity group and n=51 for the No treatment group) was used for this analysis. Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Baseline Face-Q Score | 23.3 score on a scale | Standard Deviation 20.8 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Week 8 Face-Q Score | 68.9 score on a scale | Standard Deviation 24.3 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Face-Q Change from Baseline to Week 4 | 46.5 score on a scale | Standard Deviation 27.3 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Face-Q Change from Baseline to Week 8 | 45.6 score on a scale | Standard Deviation 26.4 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Week 4 Face-Q Score | 70.0 score on a scale | Standard Deviation 23.8 |
| No Treatment | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Face-Q Change from Baseline to Week 8 | -3.8 score on a scale | Standard Deviation 12.1 |
| No Treatment | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Baseline Face-Q Score | 24.2 score on a scale | Standard Deviation 20.2 |
| No Treatment | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Week 4 Face-Q Score | 24.0 score on a scale | Standard Deviation 21.5 |
| No Treatment | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Face-Q Change from Baseline to Week 4 | 0.3 score on a scale | Standard Deviation 11.5 |
| No Treatment | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Baseline, Weeks 4 and 8 After Last Treatment. | Week 8 Face-Q Score | 21.1 score on a scale | Standard Deviation 20.1 |
Other Pre-specified
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment.
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). For a given subject to be considered a responder, at least 2 of the 3 readers must have confirmed a 1-point improvement for that subject The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)
Time frame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | Responder | 106 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | Not Responder | 90 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | Responder | 94 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | Not Responder | 89 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | Responder | 85 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | Not Responder | 92 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | Responder | 92 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | Not Responder | 96 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | Responder | 89 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | Not Responder | 97 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | Responder | 93 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by Independent Photographic Reviewers (IPR) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | Not Responder | 95 Participants |
Other Pre-specified
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment.
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score) A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | Responder | 156 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | Not Responder | 38 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | Responder | 156 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | Not Responder | 28 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | Responder | 147 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | Not Responder | 36 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | Responder | 137 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | Not Responder | 51 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | Responder | 131 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | Not Responder | 57 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | Responder | 125 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | Not Responder | 63 Participants |
Other Pre-specified
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment.
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 4 | Responder | 187 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 4 | Not Responder | 7 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | Responder | 186 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | Not Responder | 10 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | Responder | 175 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | Not Responder | 9 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | Responder | 171 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | Not Responder | 12 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | Responder | 173 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | Not Responder | 17 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | Responder | 161 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | Not Responder | 27 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | Responder | 149 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | Not Responder | 39 Participants |
Other Pre-specified
Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment.
The PR-SRS is a validated 4-point static scale for assessing perioral rhytids severity. Possible scores range from 0 (Absent) to 3 (Severe). Change = (Week 4 - Baseline score) and (Week 8 - Baseline score). A PR-SRS change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure.
Time frame: Weeks 4 and 8 after last treatment
Population: The Intent-to-Treat Population was used for this analysis. For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Responder | 145 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Not Responder | 5 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Missing values | 0 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Responder | 143 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Not Responder | 7 Participants |
| TEOSYAL RHA Redensity | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Missing values | 0 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Not Responder | 50 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Responder | 2 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Responder | 1 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Not Responder | 49 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Missing values | 0 Participants |
| No Treatment | Change From Baseline in Perioral Rhytids Severity Rating Scale (PR-SRS) Score Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Missing values | 0 Participants |
Other Pre-specified
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment.
The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)
Time frame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | > or = 1-grade improvement from Baseline | 117 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 8 | < 1-grade improvement from Baseline | 77 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | > or = 1-grade improvement from Baseline | 116 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 12 | < 1-grade improvement from Baseline | 68 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | > or = 1-grade improvement from Baseline | 112 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 16 | < 1-grade improvement from Baseline | 71 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | > or = 1-grade improvement from Baseline | 99 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 24 | < 1-grade improvement from Baseline | 89 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | > or = 1-grade improvement from Baseline | 93 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 36 | < 1-grade improvement from Baseline | 95 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | > or = 1-grade improvement from Baseline | 89 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8, 12, 16, 24, 36 and 52 After Last Treatment. | Week 52 | < 1-grade improvement from Baseline | 99 Participants |
Other Pre-specified
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment.
The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 8 - Baseline score).
Time frame: Week 8 after last treatment
Population: The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | > or = 1-grade improvement from Baseline | 93 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | < 1-grade improvement from Baseline | 53 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Missing values | 4 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | > or = 1-grade improvement from Baseline | 2 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | < 1-grade improvement from Baseline | 46 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Blinded Live Evaluator (BLE) at Week 8 After Last Treatment. | Missing values | 3 Participants |
Other Pre-specified
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment.
The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score), (Week 8 - Baseline score), (Week 12 - Baseline score), (Week 16 - Baseline score), (Week 24 - Baseline score), (Week 36 - Baseline score), (Week 52 - Baseline score)
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 4 | > or = 1-grade improvement from Baseline | 135 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 4 | < 1-grade improvement from Baseline | 59 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 8 | > or = 1-grade improvement from Baseline | 134 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 8 | < 1-grade improvement from Baseline | 62 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 12 | > or = 1-grade improvement from Baseline | 129 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 12 | < 1-grade improvement from Baseline | 55 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 16 | > or = 1-grade improvement from Baseline | 117 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 16 | < 1-grade improvement from Baseline | 66 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 24 | > or = 1-grade improvement from Baseline | 115 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 24 | < 1-grade improvement from Baseline | 75 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 36 | > or = 1-grade improvement from Baseline | 106 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 36 | < 1-grade improvement from Baseline | 82 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 52 | > or = 1-grade improvement from Baseline | 85 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 52 | < 1-grade improvement from Baseline | 103 Participants |
Other Pre-specified
Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment.
The Modified Glogau Classification Scale is a 4-point classification measuring wrinkle severity. Possible scores range from 1 (Mild) to 4 (Severe). A Glogau score change of 1-grade will be considered clinically significant. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure. Change = (Week 4 - Baseline score) and (Week 8 - Baseline score)
Time frame: Weeks 4 and 8 after last treatment
Population: The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | > or = 1-grade improvement from Baseline | 105 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | < 1-grade improvement from Baseline | 41 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Missing values | 4 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | > or = 1-grade improvement from Baseline | 106 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | < 1-grade improvement from Baseline | 41 Participants |
| TEOSYAL RHA Redensity | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Missing values | 3 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | < 1-grade improvement from Baseline | 45 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | > or = 1-grade improvement from Baseline | 2 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | > or = 1-grade improvement from Baseline | 4 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | < 1-grade improvement from Baseline | 46 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Missing values | 2 Participants |
| No Treatment | Change From Baseline of the Modified Glogau Classification of Wrinkling Rated by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Missing values | 3 Participants |
Other Pre-specified
Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment.
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied). The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 4 | Satisfied | 178 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 4 | Not Satisfied | 16 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | Satisfied | 178 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | Not Satisfied | 18 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | Satisfied | 166 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | Not Satisfied | 17 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | Satisfied | 163 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | Not Satisfied | 19 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | Satisfied | 159 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | Not Satisfied | 31 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | Satisfied | 164 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | Not Satisfied | 24 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | Satisfied | 166 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Satisfied or Very Satisfied With Study Treatment Using the Subject Satisfaction Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | Not Satisfied | 22 Participants |
Other Pre-specified
Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | Improved | 179 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | No Improvement | 15 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | Improved | 166 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | No Improvement | 18 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | Improved | 160 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | No Improvement | 23 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | Improved | 158 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | No Improvement | 30 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | Improved | 156 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | No Improvement | 32 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | Improved | 152 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | No Improvement | 36 Participants |
Other Pre-specified
Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment.
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 4 | Improved | 192 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 4 | No Improvement | 2 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | Improved | 193 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | No Improvement | 3 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | Improved | 181 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | No Improvement | 3 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | Improved | 181 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | No Improvement | 2 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | Improved | 184 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | No Improvement | 6 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | Improved | 178 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | No Improvement | 10 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | Improved | 171 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | No Improvement | 17 Participants |
Other Pre-specified
Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the pre-injection baseline photograph. The No-Treatment control group after treatment was not pooled for this exploratory outcome measure.
Time frame: Weeks 4 and 8 after last treatment
Population: The Intent-to-Treat Population was used for this analysis. The ITT Population consisted of all subjects randomized in the TEOSYAL RHA® Redensity group and all subjects randomized in the No-Treatment control group (with the notable exception of 1 subject who received treatment with study device at Visit 1 and was censored from the ITT).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Improved | 145 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | No Improvement | 1 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Missing values | 4 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Improved | 145 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | No Improvement | 2 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Missing values | 3 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | No Improvement | 47 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Improved | 0 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Improved | 2 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | No Improvement | 48 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 8 | Missing values | 2 Participants |
| No Treatment | Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Treating Investigator (TI) at Weeks 4 and 8 After Last Treatment. | Week 4 | Missing values | 3 Participants |
Other Pre-specified
Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from much improved, improved, no change, worse, to much worse. The GAI will be assessed using the baseline photograph. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 4 | Improved | 191 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 4 | No Improvement | 3 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | Improved | 186 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 8 | No Improvement | 10 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | Improved | 165 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 12 | No Improvement | 19 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | Improved | 162 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 16 | No Improvement | 20 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | Improved | 158 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 24 | No Improvement | 32 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | Improved | 152 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 36 | No Improvement | 36 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | Improved | 156 Participants |
| TEOSYAL RHA Redensity | Number of Subjects Who Scored Themselves Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale at Weeks 4, 8, 12, 16, 24, 36, 52 After Last Treatment. | Week 52 | No Improvement | 32 Participants |
Other Pre-specified
Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment.
The natural look and feel of the perioral area was assessed by subjects using an 11-point scale (ranging from 0 to 10). The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Baseline : Natural Look and Feel score > and = 7 | 91 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 4 : Natural Look and Feel score > and = 7 | 171 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 8 : Natural Look and Feel score > and = 7 | 174 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 12 : Natural Look and Feel score > and = 7 | 164 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 16 : Natural Look and Feel score > and = 7 | 158 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 24 : Natural Look and Feel score > and = 7 | 158 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 36 : Natural Look and Feel score > and = 7 | 160 Participants |
| TEOSYAL RHA Redensity | Number of Subjects With a Natural Look and Feel ≥7 of the Perioral Area, at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 52 : Natural Look and Feel score > and = 7 | 164 Participants |
Other Pre-specified
Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The FACE-Q questionnaire is composed of 6 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely'). To calculate the FACE-Q (Perioral Rhytids Domain) score, outcomes from all 6 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units. The No-Treatment control group after treatment was pooled for this exploratory outcome measure.
Time frame: Weeks 4, 8, 12, 16, 24, 36 and 52 after last treatment
Population: Of the randomized subjects (n=202), 2 subjects randomized to No-Treatment control did not receive treatment after the primary endpoint evaluation (Week 8 after randomization) and 1 subject randomized to No-Treatment control received treatment with study device, these 3 subjects are excluded from the pooled ITT population (n=199).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 8 Face-Q Score | 69.3 score on a scale | Standard Deviation 23.9 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Baseline Face-Q Score | 22.8 score on a scale | Standard Deviation 20.6 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 4 Face-Q Score | 70.4 score on a scale | Standard Deviation 22.8 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 4 | 47.5 score on a scale | Standard Deviation 26.9 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 8 | 46.5 score on a scale | Standard Deviation 26.9 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 12 | 68.3 score on a scale | Standard Deviation 23.3 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 12 | 45.4 score on a scale | Standard Deviation 26.4 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 16 | 66.8 score on a scale | Standard Deviation 24.1 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 16 | 43.4 score on a scale | Standard Deviation 26.8 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 24 | 62.0 score on a scale | Standard Deviation 26.1 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 24 | 38.9 score on a scale | Standard Deviation 29.3 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 36 | 62.1 score on a scale | Standard Deviation 25.1 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 36 | 38.8 score on a scale | Standard Deviation 28.3 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Week 52 | 59.0 score on a scale | Standard Deviation 24.1 |
| TEOSYAL RHA Redensity | Subject's Perception of Treatment Effectiveness as Per the FACE-Q Scale (Perioral Rhytid Domain) Questionnaire at Week 4, 8, 12, 16, 24, 36, and 52 After Last Treatment. | Face-Q Change from Baseline to Week 52 | 36.2 score on a scale | Standard Deviation 26.2 |