SkinPen Efficacy on Acne Scars on the Face and/or Back

NCT02646917 | Completed Results

• 1 other identifier: Bellmed001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, clinical trial will take place over a 90 day course followed by 1-month and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen device when used on both men and women on the face and/or back.

Conditions

Atrophic Acne Scar

Outcome Measures

Primary Outcomes (2)

• Severity of Acne Scars

  Goodman and Baron's Qualitative grading system. Possible scores range from 1 = mild to 4 = severe.

  Baseline, 1 month post treatment, and 6 months post treatment

• Clinician's Global Aesthetic Improvement Assessment (CGAIS)

  Clinician's Global Aesthetic Improvement Assessment: minimal score is 1- Very much improved and, maximum score is 5 -Worse: The appearance is worse than the original condition

  1 month post treatment, and 6 months post treatment

Secondary Outcomes (3)

• Photo Grading of Acne Scar Assessment

  Day 1 (Baseline), Day 30, Day 60, 1-Month post treatment and 6 Month post treatment

• Subject Self-Assessment Using SASIS

  One Month Post Treatment, 6 Month Post Treatment

• Subject Self-Assessment Using Global Aesthetic Improvement Scale (SGAIS)

  1-Month Post Treatment and 6- Month Post Treatment

Study Arms (2)

SkinPen II

ACTIVE COMPARATOR

Three treatments using SkinPen II aesthetic microneedling device to each patient, with each treatment spaced one month apart.

Procedure: Aesthetic Microneedling Treatment

SkinPen Precision

ACTIVE COMPARATOR

Three treatments using SkinPen Precision aesthetic microneedling device to each patient, with each treatment spaced one month apart.

Procedure: Aesthetic Microneedling Treatment

Interventions

Aesthetic Microneedling Treatment PROCEDURE

Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.

SkinPen II; SkinPen Precision

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18 to 60 years of age.
• Subjects in good health.
• Approximately 5 to 10 atrophic acne scars of mixed types (boxcar and/or rolling scars with some icepick scars allowed) on face and/or back that are moderate to severe.
• Desire correction of his/her acne scarring.
• Subjects of child bearing potential must take a urine pregnancy test and must test negative.
• Subjects willing to sign a photography release.
• Willingness to cooperate and participate by following study requirements.

You may not qualify if:

• Allergies to facial or general skin care products
• Presence of an active systemic or local skin disease.
• Severe solar elastosis.
• Sensitivity to topical lidocaine.
• Recent history of significant trauma to the face (\< 6 months).
• Significant scarring other than acne scars in treated area(s).
• Severe of cystic active and clinically significant acne on the area(s) to be treated.
• History of systemic granulomatous diseases.
• History of hypertrophic or keloid scars.
• Current cancerous or pre-cancerous lesions in area(s) to be treated.
• Had microdermabrasion or glycolic acid treatment to treatment area(s) within 1 month prior to study participation.
• History of chronic drug or alcohol abuse.
• Current smokers or have smoked in the last 5 years.
• History of cosmetic treatments: Skin tightening within last year, injectable filler of any type within the last year, neurotoxins within the last 3 months, ablative resurfacing laser treatments, non-ablative, rejuvanative laser treatments in last 6 months, chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of face and neck within the last 4 weeks.
• History of certain prescription medications (accutane or other retinoids, topical retinoids, prescription strength skin lightening devices, anti-wrinkle, skin lightening devices, antiplatelet agents/Anticoagulants, and/or psychiatric drugs).

Sponsors & Collaborators

• Bellus Medical, LLC: lead

Study Sites (1)

Stephens & Associates

Richardson, Texas, 45081, United States

Location

Results Point of Contact

• Title: Thomas Hitchcock, PhD
• Organization: Crown Laboratories, Inc.

THitchcock@crownlaboratories.com

8883723982

Study Officials

• Thomas J Stephens, Ph.D

  Thomas J. Stephens & Associates, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 25, 2017
• Last Updated: July 21, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Locations

US (1)