Effect of Multiple Subcisions on Rolling Acne Scars

Acne Scars Clinical Trial

Official title:

Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Multiple Subcisions on Rolling Acne Scars

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02216864
• Other study ID #: STU97928
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 65

2. Have bilateral rolling acne scars on each side of their face

3. No active or ongoing acne.

4. The subjects are in good health

5. 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.

Exclusion Criteria:

1. Under 18 years of age

2. Pregnancy or Lactation

3. Subjects who are unable to understand the protocol or to give informed consent

4. Subjects with mental illness

5. Recent Accutane use in the past 6 months

6. Subjects prone to hypertrophic and keloidal scarring

7. Subjects reporting any blood diseases (HIV, Hepatitis, etc.)

8. Subjects reporting a history of Herpes (oral or genital)

Related Conditions & MeSH terms

• Acne Scars
• Acne Vulgaris

Intervention

Procedure:
• Multiple Subcision
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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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