Lip Augmentation
Conditions
Brief summary
To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.
Detailed description
This is a multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082
Interventions
DEVICEPN40082
PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Sponsors
Symbio, LLC
Prollenium Medical Technologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all inclusion/
Exclusion criteria
; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2, and had no significant protocol violations that would affect the treatment evaluation. 2. If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period 3. Willing to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lip Fullness Grading Scale | Visit 1/Day 1 to Visit 3/Month 2, 56 Days | Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome) |
| Change From Baseline in Perioral Lines Severity Scale | Visit 1/Day 1 to Visit 3/Month 2, 56 Days | Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Patient Global Aesthetic Improvement | Visit 1/Day 1 to Visit 3/Month 2, 56 days | Change from baseline for the patient Global Aesthetic Improvement scale, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 very much improved optimal cosmetic result (better outcome) |
| Number of Participants With Investigator Global Aesthetic Improvement | Visit 1/Day 1 to Visit 3/Month 2, 56 days | Change from baseline in the Investigator Global Aesthetic Improvement score, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 = very much improved optimal cosmetic result (better outcome) |
| Number of Subjects With Decreased Swelling | Visit 1/Day 1 to Visit 3/Month 2, 56 days | Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PN40082 All subjects in this study will receive one open-label treatment with PN40082.
PN40082: PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w. | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | PN40082 |
|---|---|
| Age, Continuous | 50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 70 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 84 |
| other Total, other adverse events | 61 / 84 |
| serious Total, serious adverse events | 1 / 84 |
Outcome results
Primary
Change From Baseline in Lip Fullness Grading Scale
Lip Fullness Grading Scale is a validated 5-point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 full lips (best outcome)
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Population: Change from Baseline in Overall Lips Fullness Grading Scale at Visit3/Month 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PN40082 | Change From Baseline in Lip Fullness Grading Scale | .82 score on a scale | Standard Deviation 0.747 |
Primary
Change From Baseline in Perioral Lines Severity Scale
Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome).
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 Days
Population: Change from baseline to Visit 3/Month 2 in the perioral lines rating scale for the 17 subjects who had perioral lines treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PN40082 | Change From Baseline in Perioral Lines Severity Scale | -0.75 score on a scale | Standard Deviation 0.577 |
Secondary
Number of Participants With Investigator Global Aesthetic Improvement
Change from baseline in the Investigator Global Aesthetic Improvement score, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 = very much improved optimal cosmetic result (better outcome)
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Population: Change from baseline in the Investigator Global Aesthetic Improvement score with 1 being appearance is worse than the original condition (worse outcome) up to 5 being very much improved optimal cosmetic result (better outcome)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PN40082 | Number of Participants With Investigator Global Aesthetic Improvement | Very Much Improved (5) | 28 Participants |
| PN40082 | Number of Participants With Investigator Global Aesthetic Improvement | Much Improved (4) | 30 Participants |
| PN40082 | Number of Participants With Investigator Global Aesthetic Improvement | Improved (3) | 20 Participants |
| PN40082 | Number of Participants With Investigator Global Aesthetic Improvement | No Change (2) | 1 Participants |
| PN40082 | Number of Participants With Investigator Global Aesthetic Improvement | Worse (1) | 0 Participants |
Secondary
Number of Participants With Patient Global Aesthetic Improvement
Change from baseline for the patient Global Aesthetic Improvement scale, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 very much improved optimal cosmetic result (better outcome)
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Population: Change from baseline in the Patient Global Aesthetic Improvement scale with 5 being much improved optimal cosmetic results (better outcome) and 1 being the appearance is worse than the original condition (worse outcome)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PN40082 | Number of Participants With Patient Global Aesthetic Improvement | Very much Improved (5) | 41 Participants |
| PN40082 | Number of Participants With Patient Global Aesthetic Improvement | Much Improved (4) | 19 Participants |
| PN40082 | Number of Participants With Patient Global Aesthetic Improvement | Improved (3) | 17 Participants |
| PN40082 | Number of Participants With Patient Global Aesthetic Improvement | No change (2) | 2 Participants |
| PN40082 | Number of Participants With Patient Global Aesthetic Improvement | Worse (1) | 0 Participants |
Secondary
Number of Subjects With Decreased Swelling
Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome)
Time frame: Visit 1/Day 1 to Visit 3/Month 2, 56 days
Population: Swelling assessment at Visit 3/Month 2 with 0 = no swelling (better outcome) up to 4 = severe swelling (worse outcome)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PN40082 | Number of Subjects With Decreased Swelling | 79 Participants |