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Restylane Silk Acne Scar Efficacy Evaluation Study

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ClinicalTrials.gov Identifier: NCT02955381
Recruitment Status : Terminated (Liquidation of Research Department)
First Posted : November 4, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Schweiger Dermatology, PLLC

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE March 28, 2017
Actual Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
1 grade improvement of ASRS from baseline [ Time Frame: Baseline-6 Months post first injection. ]
The primary endpoint is a one grade improvement of the acne scar from baseline as rated on the ASRS.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02955381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Statistically significant improvement of the acne scar from baseline [ Time Frame: Baseline-6 Months post first injection. ]
    A significant improvement of the acne scar from baseline as rated by the
  • Statistically significant improvement of the skin quality from baseline [ Time Frame: Baseline-6 Months post first injection. ]
    A significant improvement of the skin quality of the treatment area as rated by the investigator using the skin quality assessment scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 3, 2016)
Statistically significant acne scar area reduction from baseline. [ Time Frame: Baseline-6 Months post first injection. ]
The first exploratory endpoint is a significant reduction of acne scar area as measured by the VECTRA system 6 months post first treatment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Restylane Silk Acne Scar Efficacy Evaluation Study
Official Title  ICMJE 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
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne
  • Acne Scars
  • AdverseEvent
Intervention  ICMJE
  • Device: Restylane Silk, 1.0 ml
    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.
  • Device: Saline, 1.0 ml
    Simple saline solution. To be used as placebo (control). No active ingredients.
Study Arms  ICMJE
  • Experimental: Restylane Silk, 1.0 ml
    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.
    Intervention: Device: Restylane Silk, 1.0 ml
  • Placebo Comparator: Placebo (Saline), 1.0 ml
    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.
    Intervention: Device: Saline, 1.0 ml
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
30
Actual Study Completion Date  ICMJE April 18, 2019
Actual Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or non-pregnant female subjects on an acceptable form of birth control aged 22-55 years of age.
  2. Willing to refrain from undergoing any procedures to repair or augment any acne scar in the treatment area during the study.
  3. 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.
  4. Signed informed consent prior to conducting any study procedures.
  5. Willing to refrain from undergoing any cosmetic procedures in the treatment area during the study.
  6. 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.
  7. Acne scars that are classified as either ice pick, rolling, or boxcar acne scars.
  8. ≤15 pustules/papules on the face at the time of screening and ≤ 2 nodules, and no cysts at Baseline.
  9. Willing to attend all study visits and comply with protocol

Exclusion Criteria:

  1. Subjects with active cystic acne at screening (> 2 nodules or any cysts present at Baseline).
  2. Use of antibiotics 2-weeks prior to screening.
  3. Use of retinoids 2-weeks prior to screening.
  4. Use of salicylic acid or benzoyl peroxide 7 days prior to screening.
  5. Excessive facial hair, skin conditions, facial tattoos, or other dermatologic marks that would obscure the treatment area.
  6. Use of Isotretinoin (Accutane) 6 months prior to screening.
  7. Semi-permanent or permanent injection in the face 3 months prior to screening.
  8. History of bleeding disorders.
  9. Use of blood thinners (i.e warfarin (Coumadin), clopidogrel bisulfate (Plavix), etc.) 1 month prior to screening.
  10. 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.
  11. 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.
  12. Laser or light (red and blue) treatments for acne 3 months prior to screening.
  13. Resurfacing procedures (CO2 , Erbium, Fraxel, etc.) performed 6 months prior to screening.
  14. Any chemical peels in the last 30 days prior to screening.
  15. Hypersensitivity to amid-type local anesthetics.
  16. Any cortisol steroid or ILK injection 30 days prior to screening
  17. Subjects with a history of diabetes.
  18. Any medical condition or diagnosis which in the investigator's opinion would disqualify them from the research study.
  19. History of abuse with the use of alcohol or drugs.
  20. Participation in a clinical trial or use of an investigational product in the past 30 days.
  21. Subjects who are considered health risks for participation in the study or the investigator determines not to be suitable.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02955381
Other Study ID Numbers  ICMJE SDG 02-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is an investigator initiated study and will use the primary data to create a final data report. Individual patient data will not be available to other researchers.
Responsible Party Schweiger Dermatology, PLLC
Study Sponsor  ICMJE Schweiger Dermatology, PLLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric S Schweiger, M.D. CEO & Chief Medical Officer
Study Director: Margaret J Tropeano, BS Clinical Research Director
PRS Account Schweiger Dermatology, PLLC
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP