Effect of Subcision and Suction on Acne Scars
Primary Purpose
Acne Scars
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suction
Subcision
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars
Eligibility Criteria
Inclusion Criteria:
- Age 18 and over
- Have bilateral rolling acne scars
- Are in good health
- Subject has the willingness and 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
- Unable to understand the protocol or give informed consent
- Has mental illness
- Recent Accutane use in the past 6 months
- Prone to hypertrophic and keloidal scarring
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Subcision & Suction
Subcision
Arm Description
Standard treatment for acne scars followed by suction.
Standard treatment for acne scars only
Outcomes
Primary Outcome Measures
Change in acne scarring compared to baseline after treatments
The change in acne scarring is measured using a global scarring grading system to compare baseline scarring to the treatments.
Secondary Outcome Measures
Full Information
NCT ID
NCT01696513
First Posted
September 14, 2012
Last Updated
February 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT01696513
Brief Title
Effect of Subcision and Suction on Acne Scars
Official Title
Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Subcision and Suctioning With a Microdermabrasion Device on Rolling Acne Scars
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2012 (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
No
5. Study Description
Brief Summary
The primary objective of this study is to determine whether the use of standard treatment in conjunction with suction will improve acne scars compared to a standard treatment alone.
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subcision & Suction
Arm Type
Experimental
Arm Description
Standard treatment for acne scars followed by suction.
Arm Title
Subcision
Arm Type
Active Comparator
Arm Description
Standard treatment for acne scars only
Intervention Type
Procedure
Intervention Name(s)
Suction
Intervention Type
Procedure
Intervention Name(s)
Subcision
Primary Outcome Measure Information:
Title
Change in acne scarring compared to baseline after treatments
Description
The change in acne scarring is measured using a global scarring grading system to compare baseline scarring to the treatments.
Time Frame
Baseline and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 and over
Have bilateral rolling acne scars
Are in good health
Subject has the willingness and 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
Unable to understand the protocol or give informed consent
Has mental illness
Recent Accutane use in the past 6 months
Prone to hypertrophic and keloidal scarring
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 Subcision and Suction on Acne Scars
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