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

NCT ID: NCT02646917

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-07-25

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.

Detailed Description

At least 20 subjects of varying Fitzpatrick skin types will be admitted to the trial for treatment on their moderate to severe acne scars on the face and/or back. Implementation of needle depths ranging from 0.25 mm to 2.0 mm will depend on severity of scars and their location. Each subject will undergo 3 treatments in 30 day increments and will take pre-treatment images as well as 1-month and 6-months post treatment images. Assessment will be based on the Goodman and Baron's grading system, the Clinician's Global Aesthetic Improvement Scale, as well as a self-assessment.

Conditions

Atrophic Acne Scar

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SkinPen II

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

Group Type: ACTIVE_COMPARATOR

Aesthetic Microneedling Treatment

Intervention Type: 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 Precision

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

Group Type: ACTIVE_COMPARATOR

Aesthetic Microneedling Treatment

Intervention Type: 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.

Interventions

Aesthetic Microneedling Treatment

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).
• Nursing, pregnant, or planning to become pregnant during study.
• Current or pre-existing dermatologic diseases on the face or body (psoriasis, rosacea, eczema, etc.)
• History of immunosupression/immune deficiency disorders.
• Current or history of uncontrolled disease such as asthma, diabetes, hyperthyroidism, etc.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bellus Medical, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J Stephens, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Thomas J. Stephens & Associates, Inc.

Locations

Stephens & Associates

Richardson, Texas, United States

Countries

United States

Other Identifiers

Bellmed001

Identifier Type: -

Identifier Source: org_study_id