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Restylane Silk Acne Scar Efficacy Evaluation Study

Primary Purpose

Acne, Acne Scars, AdverseEvent

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restylane Silk, 1.0 ml
Saline, 1.0 ml
Sponsored by
Schweiger Dermatology, PLLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

22 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Schweiger Dermatology, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Restylane Silk, 1.0 ml

Placebo (Saline), 1.0 ml

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Statistically significant improvement of the acne scar from baseline
A significant improvement of the acne scar from baseline as rated by the
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.

Full Information

First Posted
November 2, 2016
Last Updated
May 8, 2019
Sponsor
Schweiger Dermatology, PLLC
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1. Study Identification

Unique Protocol Identification Number
NCT02955381
Brief Title
Restylane Silk Acne Scar Efficacy Evaluation Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Liquidation of Research Department
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
April 18, 2019 (Actual)
Study Completion Date
April 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schweiger Dermatology, PLLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Acne Scars, AdverseEvent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Restylane Silk, 1.0 ml
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Saline), 1.0 ml
Arm Type
Placebo Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Restylane Silk, 1.0 ml
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Saline, 1.0 ml
Intervention Description
Simple saline solution. To be used as placebo (control). No active ingredients.
Primary Outcome Measure Information:
Title
1 grade improvement of ASRS from baseline
Description
The primary endpoint is a one grade improvement of the acne scar from baseline as rated on the ASRS.
Time Frame
Baseline-6 Months post first injection.
Secondary Outcome Measure Information:
Title
Statistically significant improvement of the acne scar from baseline
Description
A significant improvement of the acne scar from baseline as rated by the
Time Frame
Baseline-6 Months post first injection.
Title
Statistically significant improvement of the skin quality from baseline
Description
A significant improvement of the skin quality of the treatment area as rated by the investigator using the skin quality assessment scale.
Time Frame
Baseline-6 Months post first injection.
Other Pre-specified Outcome Measures:
Title
Statistically significant acne scar area reduction from baseline.
Description
The first exploratory endpoint is a significant reduction of acne scar area as measured by the VECTRA system 6 months post first treatment
Time Frame
Baseline-6 Months post first injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric S Schweiger, M.D.
Organizational Affiliation
CEO & Chief Medical Officer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret J Tropeano, BS
Organizational Affiliation
Clinical Research Director
Official's Role
Study Director
Facility Information:
Facility Name
Schweiger Dermatology, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
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Citation
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Restylane Silk Acne Scar Efficacy Evaluation Study

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