Effect of Multiple Subcisions on Rolling Acne Scars

NCT02216864 | Active Not Recruiting DMC

• 1 other identifier: STU97928
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether the use of multiple subcisions over several visits will improve the appearance of rolling acne scars compared to no treatment. This study was a pilot study designed to determine feasibility of this procedure.

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Change in acne scarring compared to baseline after treatments

  The change in acne scarring is measured using a quantitative global scarring grading system to compare baseline to the treatment.

  Baseline and 36 weeks

Study Arms (2)

Multiple Subcision

EXPERIMENTAL

Subjects will receive multiple subcision treatments to their randomized side of the face 5 times total spaced 4 weeks apart.

Procedure: Multiple Subcision

Control

NO INTERVENTION

Subjects will receive no intervention control on the other side of the face.

Interventions

Multiple Subcision PROCEDURE

At the start of the procedure, a straight vitrectomy knife will be inserted subdermally and will be slowly advanced parallel to the dermis. Rapid advancement and retraction of the needle under the scarred area in a lancing motion will be performed to abrade the underside of the dermis followed by side to side sweeping motions attempting to break any fibrous attachments to the deeper tissues.

Multiple Subcision

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65
• Have bilateral rolling acne scars on each side of their face
• No active or ongoing acne.
• The subjects are in good health
• The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

You may not qualify if:

• Under 18 years of age
• Pregnancy or Lactation
• Subjects who are unable to understand the protocol or to give informed consent
• Subjects with mental illness
• Recent Accutane use in the past 6 months
• Subjects prone to hypertrophic and keloidal scarring
• Subjects reporting any blood diseases (HIV, Hepatitis, etc.)
• Subjects reporting a history of Herpes (oral or genital)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)