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Restylane Silk Acne Scar Efficacy Evaluation Study

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ClinicalTrials.gov Identifier: NCT02955381
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Schweiger Dermatology, PLLC

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.

Condition or disease Intervention/treatment Phase
Acne Acne Scars AdverseEvent Device: Restylane Silk, 1.0 ml Device: Saline, 1.0 ml Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
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.
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.

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.
Device: Saline, 1.0 ml
Simple saline solution. To be used as placebo (control). No active ingredients.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955381


Contacts
Contact: Margaret J Tropeano, BS 646-604-4344 mtropeano@schweigerderm.com
Contact: Abrita Chowdhury, BS (646) 604-4374 achowdhury@schweigerderm.com

Locations
United States, New York
Schweiger Dermatology, PLLC Recruiting
New York, New York, United States, 10022
Contact: Margaret J Tropeano, BS    646-604-4344    mtropeano@schweigerderm.com   
Contact: Abrita Chowdhury, BS    (646) 604-4374    achowdhury@schweigerderm.com   
Principal Investigator: Eric S Schweiger, MD         
Sub-Investigator: Diana Palmisano, PA-C         
Sub-Investigator: Laura Palmisano, PA-C         
Sub-Investigator: Jeremy S Fenton, MD         
Sponsors and Collaborators
Schweiger Dermatology, PLLC
Investigators
Principal Investigator: Eric S Schweiger, M.D. CEO & Chief Medical Officer
Study Director: Margaret J Tropeano, BS Clinical Research Director

Publications:
Fife D, Zachary CB. Combining techniques for treating acne scars. Current Dermatology Reports. 2012;1:82-88.
Werschler, Phillip, et al.
Werschler, P. (2016). Severe - Depth = >2.5 mm in depth. Visibility = Substantial shadowing with tangential lighting. Journal of Drugs in Dermatology, 15(5), 518-525

Responsible Party: Schweiger Dermatology, PLLC
ClinicalTrials.gov Identifier: NCT02955381     History of Changes
Other Study ID Numbers: SDG 02-2016
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents