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Effect of Multiple Subcisions on Rolling Acne Scars

Primary Purpose

Acne Scars

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Multiple Subcision

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Sites / Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multiple Subcision

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02216864

First Posted

August 12, 2014

Last Updated

February 17, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT02216864

Brief Title

Effect of Multiple Subcisions on Rolling Acne Scars

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2014 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Acne Scars

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multiple Subcision

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Multiple Subcision

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in acne scarring compared to baseline after treatments

Description

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

Time Frame

Baseline and 36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murad Alam, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine, Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

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Effect of Multiple Subcisions on Rolling Acne Scars

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