Lower Face Folds and Lines
Conditions
Brief summary
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
Interventions
DEVICERestylane Defyne
Up to 2 milliliters (ml) of Restylane Defyne per treatment site (chin and surrounding area) with maximum of total 4 ml at baseline, up to 2 ml of Restylane Defyne per NLF and ML at week 3 and optional up to 2 ml of Restylane Defyne per facial half for NLF and ML in combination with a total of 2 ml in the chin and surrounding area at week 6.
Sponsors
Galderma R&D
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
No
Inclusion criteria
* Subjects willed to comply with the requirements of the study and provided a signed written informed consent * Subjects willed to undergo augmentation and correction therapy in the studied indications * Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins * Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim * Participation in any interventional clinical study within 30 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | At Week 3 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from worse to very much improved as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported. |
| Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | At Week 6 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from worse to very much improved as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported. |
| Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | At Week 9 | Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from worse to very much improved as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | At Week 3, 6, and 9 | The treating investigator assessed the naturalness of the treatment result based on review of baseline photographs and live assessment on how much they agreed or disagreed to the statement as follows: The treatment results were natural looking. The investigator's questionnaire for naturalness of the treatment result were categorized into strongly agree, agree, neither agree or disagree, disagree and strongly disagree. The percentage of participants with naturalness of the treatment result as assessed by treating investigator were reported. |
| Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | At Week 3, 6 and 9 | Participants completed 7 questions of subject satisfaction Questionnaire which are listed as follows: a) My first treatment improved my appearance, b) Compared to my first treatment, treating both areas in combination improved appearance, c) I am satisfied with the contour of my lower face after treatment, d) I am satisfied with the shape of my chin, e) I am satisfied with how well defined my chin looks, f) I feel more attractive after treatment, g) I feel comfortable being photographed. SSQ was balanced on 5-point scale assessing subject satisfaction with study treatment. Possible scores range was 1-Very Satisfied, 2-Satisfied, 3-Neither satisfied nor dissatisfied, 4-Dissatisfied, 5-Very Dissatisfied. Percentage of participants who strongly agreed or agreed to the SSQ were reported. |
Countries
Brazil, Italy, United States
Participant flow
Recruitment details
The study was conducted at 2 sites each in Brazil and Unites States,1 site in Italy from 07 Dec 2020 to 15 Sept 2021.
Participants by arm
| Arm | Count |
|---|---|
| Down-up Participants in this group received injections in the chin and surrounding area with up to 2 mL Restylane Defyne per treatment site with a maximum of 4 mL in total at Baseline and in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. | 31 |
| Top-down Participants in this group received injections in the NLFs and MLs with up to 2 mL of Restylane Defyne per NLF and up to 2 mL per ML of Restylane Defyne at Baseline and in the chin and surrounding area with up to 2 mL of Restylane Defyne per treatment site with a maximum of 4 mL in total at Week 3 (second injection). An optional touch-up was administered to participants who had not achieved the optimal aesthetic improvement as agreed between participant and investigator at 6 weeks after second injection. | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Not Treated | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Top-down | Total | Down-up |
|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 11.4 | 44.1 years STANDARD_DEVIATION 11.1 | 43.8 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 29 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Types Type I | 2 Participants | 2 Participants | 0 Participants |
| Fitzpatrick Skin Types Type II | 7 Participants | 18 Participants | 11 Participants |
| Fitzpatrick Skin Types Type III | 14 Participants | 24 Participants | 10 Participants |
| Fitzpatrick Skin Types Type IV | 6 Participants | 15 Participants | 9 Participants |
| Fitzpatrick Skin Types Type V | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Types Type VI | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 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 | 29 Participants | 58 Participants | 29 Participants |
| Sex: Female, Male Female | 18 Participants | 39 Participants | 21 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 29 |
| other Total, other adverse events | 7 / 32 | 5 / 29 |
| serious Total, serious adverse events | 0 / 32 | 0 / 29 |
Outcome results
Primary
Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from worse to very much improved as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the treating investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Number of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 3 were reported.
Time frame: At Week 3
Population: MITT population included all participants who were treated at both Baseline and Week 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Down-up | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Improved | 3 Participants |
| Down-up | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Very Much Improved | 18 Participants |
| Down-up | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Much Improved | 10 Participants |
| Top-down | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Improved | 9 Participants |
| Top-down | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Much Improved | 8 Participants |
| Top-down | Number of Participants (Responders) With Aesthetic Improvement by the Treating Investigator Assessment Using Global Aesthetic Improvement Scale (GAIS) at Week 3 | Very Much Improved | 12 Participants |
Primary
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from worse to very much improved as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 6 were reported.
Time frame: At Week 6
Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Down-up | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Improved | 6.7 Percentage of participants |
| Down-up | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Very Much Improved | 56.7 Percentage of participants |
| Down-up | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Much Improved | 36.7 Percentage of participants |
| Top-down | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Improved | 6.9 Percentage of participants |
| Top-down | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Much Improved | 17.2 Percentage of participants |
| Top-down | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 6 | Very Much Improved | 75.9 Percentage of participants |
Primary
Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9
Aesthetic improvement in chin and nasolabial fold/marionette line, and in combination was assessed on a 5-graded GAIS from worse to very much improved as follows; very much improved (optimal cosmetic result for the participant), much improved (marked improvement in appearance from the original condition, but not completely optimal for this participant), improved (obvious improvement in appearance from the original condition), no change (the appearance is essentially the same as the original condition), worse (the appearance is worse than the original condition). Responder was defined as a participant with a rating of at least improved as assessed by the Treating Investigator (assessed as very much improved, much improved or improved) compared to pre-treatment. Percentage of participants (responders) with aesthetic improvement based on treating investigator assessment using GAIS at Week 9 were reported.
Time frame: At Week 9
Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Down-up | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Very Much Improved | 76.7 Percentage of participants |
| Down-up | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Much Improved | 20.0 Percentage of participants |
| Down-up | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Improved | 3.3 Percentage of participants |
| Top-down | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Very Much Improved | 71.4 Percentage of participants |
| Top-down | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Much Improved | 17.9 Percentage of participants |
| Top-down | Percentage of Participants (Responders) With Aesthetic Improvement Based on Treating Investigator Assessment Using GAIS at Week 9 | Improved | 10.7 Percentage of participants |
Secondary
Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ)
Participants completed 7 questions of subject satisfaction Questionnaire which are listed as follows: a) My first treatment improved my appearance, b) Compared to my first treatment, treating both areas in combination improved appearance, c) I am satisfied with the contour of my lower face after treatment, d) I am satisfied with the shape of my chin, e) I am satisfied with how well defined my chin looks, f) I feel more attractive after treatment, g) I feel comfortable being photographed. SSQ was balanced on 5-point scale assessing subject satisfaction with study treatment. Possible scores range was 1-Very Satisfied, 2-Satisfied, 3-Neither satisfied nor dissatisfied, 4-Dissatisfied, 5-Very Dissatisfied. Percentage of participants who strongly agreed or agreed to the SSQ were reported.
Time frame: At Week 3, 6 and 9
Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, number analyzed signifies participants who were evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | My first treatment improved my appearance at Week 3 | 100 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | My first treatment improved my appearance at Week 6 | 93.3 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | My first treatment improved my appearance at Week 9 | 96.7 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with how well-defined my chin looks at Week 3 | 93.5 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with how well-defined my chin looks at Week 6 | 93.3 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel more attractive after treatment at Week 6 | 93.3 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel more attractive after treatment at Week 9 | 90.0 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel comfortable being photographed at Week 3 | 77.4 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel comfortable being photographed at Week 6 | 86.7 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel comfortable being photographed at Week 9 | 90.0 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | Compared to my first treatment, treating both areas in combination improved my appearance at Week 6 | 100.0 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | Compared to my first treatment, treating both areas in combination improved my appearance at Week 9 | 100.0 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the shape of my chin at Week 3 | 96.8 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the shape of my chin at Week 6 | 96.7 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the shape of my chin at Week 9 | 100.0 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the contour of my lower face after treatment at Week 6 | 96.7 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the contour of my lower face after treatment at Week 9 | 100 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the contour of my lower face after treatment at Week 3 | 96.8 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with how well-defined my chin looks at Week 9 | 96.7 Percentage of participants |
| Down-up | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel more attractive after treatment at Week 3 | 80.6 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel comfortable being photographed at Week 9 | 78.6 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | My first treatment improved my appearance at Week 3 | 93.1 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the shape of my chin at Week 9 | 92.9 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | My first treatment improved my appearance at Week 6 | 93.1 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | Compared to my first treatment, treating both areas in combination improved my appearance at Week 6 | 89.7 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | My first treatment improved my appearance at Week 9 | 89.3 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the contour of my lower face after treatment at Week 3 | 79.3 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with how well-defined my chin looks at Week 6 | 86.2 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | Compared to my first treatment, treating both areas in combination improved my appearance at Week 9 | 92.9 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with how well-defined my chin looks at Week 9 | 89.3 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel more attractive after treatment at Week 3 | 72.4 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the contour of my lower face after treatment at Week 6 | 93.1 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel more attractive after treatment at Week 6 | 75.9 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the shape of my chin at Week 3 | 41.4 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel more attractive after treatment at Week 9 | 85.7 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with how well-defined my chin looks at Week 3 | 37.9 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel comfortable being photographed at Week 3 | 55.2 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the shape of my chin at Week 6 | 89.7 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I feel comfortable being photographed at Week 6 | 75.9 Percentage of participants |
| Top-down | Percentage of Participants Agreeing With Statements in a Satisfaction Questionnaire (SSQ) | I am satisfied with the contour of my lower face after treatment at Week 9 | 96.4 Percentage of participants |
Secondary
Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator
The treating investigator assessed the naturalness of the treatment result based on review of baseline photographs and live assessment on how much they agreed or disagreed to the statement as follows: The treatment results were natural looking. The investigator's questionnaire for naturalness of the treatment result were categorized into strongly agree, agree, neither agree or disagree, disagree and strongly disagree. The percentage of participants with naturalness of the treatment result as assessed by treating investigator were reported.
Time frame: At Week 3, 6, and 9
Population: MITT population included all participants who were treated at both Baseline and Week 3. Here, number analyzed signifies participants who were evaluable for this outcome measure at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Down-up | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 9: Agree | 26.7 Percentage of participants |
| Down-up | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 6: Agree | 10.0 Percentage of participants |
| Down-up | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 3: Strongly agree | 90.3 Percentage of participants |
| Down-up | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 3: Agree | 9.7 Percentage of participants |
| Down-up | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 6: Strongly agree | 90.0 Percentage of participants |
| Down-up | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 9: Strongly agree | 73.3 Percentage of participants |
| Top-down | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 6: Agree | 10.3 Percentage of participants |
| Top-down | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 3: Agree | 10.3 Percentage of participants |
| Top-down | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 9: Strongly agree | 89.3 Percentage of participants |
| Top-down | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 9: Agree | 10.7 Percentage of participants |
| Top-down | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 6: Strongly agree | 89.7 Percentage of participants |
| Top-down | Percentage of Participants With Naturalness of the Treatment Result as Assessed by Treating Investigator | Naturalness at Week 3: Strongly agree | 89.7 Percentage of participants |