Restylane Silk Acne Scar Efficacy Evaluation Study

Study Overview
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Brief Summary
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Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events will be captured at each visit only by the unblinded investigator.

Detailed Description
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Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The blinded investigators will evaluate the target scar using the Acne Scar Rating Scale (ASRS), rate the target acne scar regarding treatment effect on a -5 (Markedly worse), to 0 (Neutral Improvement), to 5 (Markedly Improved (Clear or nearly clear)) point scale, and evaluate the skin quality (regarding brightness, fullness, smoothness, and clarity). Subjects will give the acne scar a score on the subject VAS acne scar satisfaction scale marking between 0 (Not satisfied with Acne Scar at Day 0) and 10 (Extremely Satisfied with Acne Scar at Day 0). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. The subject will have their vital signs taken, complete a symptom diary (only if the subject experiences side effects or adverse events), complete a DLQI, and have photos (VECTRA and 2D digital photographs) taken of the treatment area. Efficacy measures will only be completed by the blinded investigator. Safety and adverse events will be captured at each visit only by the unblinded investigator.

Official Title
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6 Month Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Small Particle Hyaluronic Acid to Treat Acne Scars Located on the Cheeks and Forehead

Conditions
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Acne, Acne Scars, AdverseEvent

Intervention / Treatment
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* Device: Restylane Silk, 1.0 ml
* Device: Saline, 1.0 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female subjects on an acceptable form of birth control aged 22-55 years of age. Willing to refrain from undergoing any procedures to repair or augment any acne scar in the treatment area during the study. Female subjects with a negative pregnancy test confirmed at screening and on an acceptable form of birth control. Acceptable forms of birth control on this study include oral or injectable contraceptive, contraceptive patches, Depo-Provera, NuvaRing, Implanon, double barrier methods, IUD, same sex partner, or abstinence. Males will be required to use an acceptable method of birth control: vasectomy, double-barrier method, condom with spermicidal lube, or abstinence. Signed informed consent prior to conducting any study procedures. Willing to refrain from undergoing any cosmetic procedures in the treatment area during the study. At least one acne scar located on the cheeks or forehead to be ≥ 3 mm and ≤ 10 mm in diameter, and rated as ≥3 on the ASRS at day 0. Subjects may have up to three qualifying acne scars determined eligible for treatment at screening. Acne scars that are classified as either ice pick, rolling, or boxcar acne scars. ≤15 pustules/papules on the face at the time of screening and ≤ 2 nodules, and no cysts at Baseline. Willing to attend all study visits and comply with protocol Exclusion Criteria: Subjects with active cystic acne at screening (> 2 nodules or any cysts present at Baseline). Use of antibiotics 2-weeks prior to screening. Use of retinoids 2-weeks prior to screening. Use of salicylic acid or benzoyl peroxide 7 days prior to screening. Excessive facial hair, skin conditions, facial tattoos, or other dermatologic marks that would obscure the treatment area. Use of Isotretinoin (Accutane) 6 months prior to screening. Semi-permanent or permanent injection in the face 3 months prior to screening. History of bleeding disorders. Use of blood thinners (i.e warfarin (Coumadin), clopidogrel bisulfate (Plavix), etc.) 1 month prior to screening. Acne scars that are considered post-inflammatory erythematous, post-inflammatory hyperpigmentation, varicella (chicken pox) scars, or perifollicular elastolysis will not be allowed to be identified as the target acne scars. These types of scars are still allowed to be present but cannot be selected. Acne scars that are located in the glabella and temple regions. Acne scars located in these regions will not be allowed to be selected as a target or additional acne scar. As well, scars located in these areas will not be allowed to be treated during the study. Subjects are allowed to have acne scars located in these areas but cannot have them selected for evaluation or treated during the study. Laser or light (red and blue) treatments for acne 3 months prior to screening. Resurfacing procedures (CO2 , Erbium, Fraxel, etc.) performed 6 months prior to screening. Any chemical peels in the last 30 days prior to screening. Hypersensitivity to amid-type local anesthetics. Any cortisol steroid or ILK injection 30 days prior to screening Subjects with a history of diabetes. Any medical condition or diagnosis which in the investigator's opinion would disqualify them from the research study. History of abuse with the use of alcohol or drugs. Participation in a clinical trial or use of an investigational product in the past 30 days. Subjects who are considered health risks for participation in the study or the investigator determines not to be suitable.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Silk, 1.0 ml<br>Subjects must have at least 1 but up to 3 acne scars ≥3 mm and ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk) in each scar (up to 3 acne scars) at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will remain blinded to the treatment administered to them during these visits. | Device: Restylane Silk, 1.0 ml<br>* Restylane® Silk was approved in 2014 submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.<br>|
| Placebo Comparator: Placebo (Saline), 1.0 ml<br>Subjects must have at least 1 but up to 3 acne scars ≥3 mm and ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Placebo (Saline)) in each scar (up to 3 acne scars) at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will remain blinded to the treatment administered to them during these visits. | Device: Saline, 1.0 ml<br>* Simple saline solution. To be used as placebo (control). No active ingredients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 grade improvement of ASRS from baseline | The primary endpoint is a one grade improvement of the acne scar from baseline as rated on the ASRS. | Baseline-6 Months post first injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically significant improvement of the acne scar from baseline | A significant improvement of the acne scar from baseline as rated by the | Baseline-6 Months post first injection. | 
| Statistically significant improvement of the skin quality from baseline | A significant improvement of the skin quality of the treatment area as rated by the investigator using the skin quality assessment scale. | Baseline-6 Months post first injection. |