Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
Interventions
DEVICERestylane Lidocaine
Hyaluronic acid based filler
OTHERNo-treatment control
No-treatment control
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Intent to undergo treatment of depressed acne scars * Presence of 5-20 scars with a diameter of up to approximately 4 mm within the treatment area * Similar type, size and number of scars on both cheeks * Men or non-pregnant, non-breast feeding women * Fitzpatrick skin type I-IV * Signed and dated informed consent to participate in the study
Exclusion criteria
* Presence of more than 3 scars per cheek (within the treatment area) of the following types: icepick scars or atrophic acne scars with a diameter of \> 4 mm. * Active acne with inflammatory component * Use of per oral or topical (facial) substances containing retinoids, bensoyl peroxide, alpha-hydroxy acid at concentrations above 10%, beta-hydroxy acid at a concentration above 2%, or antibiotic treatment for active acne within 4 months before treatment * Use of isotretinoin within 6 months before treatment * Post-surgical scars in the treatment area * Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the treatment area * Previous tissue augmenting therapy, contouring or revitalisation treatment with Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), in the treatment area within 24 months before treatment * Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler such as hyaluronic acid (HA) or collagen in the treatment area within 12 months before treatment * Previous tissue revitalisation treatment with neurotoxin, laser or light, mesotherapy, chemical peeling or dermabrasion in the treatment area within 6 months before treatment * Previous surgery including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area * Any medical condition that, in the opinion of the treating Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek | Month 3 | Overall scar severity assessed by blinded evaluator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Month 1, Month 3 | Assessed by blinded evaluator |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Split-face: Treatment/No-treatment Control All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Subject request | 2 |
Baseline characteristics
| Characteristic | Split-face: Treatment/No-treatment Control |
|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 9.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment Germany | 49 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 9 / 49 |
| serious Total, serious adverse events | 1 / 49 |
Outcome results
Primary
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
Overall scar severity assessed by blinded evaluator.
Time frame: Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Split-face: Treatment/No-treatment Control | Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek | 81 percentage of participants |
Secondary
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Assessed by blinded evaluator
Time frame: Month 1, Month 3
Population: 48 participants at Month 1, 47 participants at Month 3, due to withdrawal. Split-face design: overall 48 participants, with one treated cheek and one cheek as no-treatment control.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Split-face: Treatment/No-treatment Control | Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Month 1 | 0 percentage of participants |
| Split-face: Treatment/No-treatment Control | Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Month 3 | 6 percentage of participants |
| Treatment | Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Month 1 | 96 percentage of participants |
| Treatment | Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Month 3 | 83 percentage of participants |