Restylane Silk Acne Scar Efficacy Evaluation Study

NCT02955381 | Terminated FDA Device

• 1 other identifier: SDG 02-2016
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Acne Scars; AdverseEvent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Statistically significant improvement of the acne scar from baseline

  Baseline-6 Months post first injection.

• Statistically significant improvement of the skin quality from baseline

  Baseline-6 Months post first injection.

Other Outcomes (1)

• Statistically significant acne scar area reduction from baseline.

  Baseline-6 Months post first injection.

Study Arms (2)

Restylane Silk, 1.0 ml

EXPERIMENTAL

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

Placebo (Saline), 1.0 ml

PLACEBO COMPARATOR

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

Interventions

Restylane Silk, 1.0 ml DEVICE

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.

Restylane Silk, 1.0 ml

Saline, 1.0 ml DEVICE

Simple saline solution. To be used as placebo (control). No active ingredients.

Placebo (Saline), 1.0 ml

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schweiger Dermatology, PLLC: lead

Study Sites (1)

Schweiger Dermatology, PLLC

New York, New York, 10022, United States

Location

Related Publications (16)

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• Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.

  PMID: 18488885 BACKGROUND

• Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.

  PMID: 7955470 BACKGROUND

• Koo JY, Smith LL. Psychologic aspects of acne. Pediatr Dermatol. 1991 Sep;8(3):185-8. doi: 10.1111/j.1525-1470.1991.tb00856.x.

  PMID: 1836060 BACKGROUND

• Rivera AE. Acne scarring: a review and current treatment modalities. J Am Acad Dermatol. 2008 Oct;59(4):659-76. doi: 10.1016/j.jaad.2008.05.029. Epub 2008 Jul 26.

  PMID: 18662839 BACKGROUND

• Tsao SS, Dover JS, Arndt KA, Kaminer MS. Scar management: keloid, hypertrophic, atrophic, and acne scars. Semin Cutan Med Surg. 2002 Mar;21(1):46-75. doi: 10.1016/s1085-5629(02)80719-2. No abstract available.

  PMID: 11911537 BACKGROUND

• Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.

  PMID: 11423843 BACKGROUND

• Sadick NS, Palmisano L. Case study involving use of injectable poly-L-lactic acid (PLLA) for acne scars. J Dermatolog Treat. 2009;20(5):302-7. doi: 10.1080/09546630902817879.

  PMID: 19340629 BACKGROUND

• Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.

  PMID: 20480786 BACKGROUND

• Brandt FS, Cazzaniga A. Hyaluronic acid fillers: Restylane and Perlane. Facial Plast Surg Clin North Am. 2007 Feb;15(1):63-76, vii. doi: 10.1016/j.fsc.2006.11.002.

  PMID: 17317557 BACKGROUND

• Fife D, Zachary CB. Combining techniques for treating acne scars. Current Dermatology Reports. 2012;1:82-88.

  BACKGROUND

• Werschler, Phillip, et al.

  BACKGROUND

• Cohen JL. Understanding, avoiding, and managing dermal filler complications. Dermatol Surg. 2008 Jun;34 Suppl 1:S92-9. doi: 10.1111/j.1524-4725.2008.34249.x.

  PMID: 18547189 BACKGROUND

• Hession MT, Graber EM. Atrophic acne scarring: a review of treatment options. J Clin Aesthet Dermatol. 2015 Jan;8(1):50-8.

  PMID: 25610524 BACKGROUND

• Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological study. Dermatol Surg. 1998 Dec;24(12):1317-25. doi: 10.1111/j.1524-4725.1998.tb00007.x.

  PMID: 9865196 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Eric S Schweiger, M.D.

  CEO & Chief Medical Officer

  PRINCIPAL INVESTIGATOR

• Margaret J Tropeano, BS

  Clinical Research Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: March 28, 2017
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)