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Effect of Multiple Subcisions on Rolling Acne Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02216864
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Last Update Posted : January 5, 2022
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Acne Scars Procedure: Multiple Subcision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Multiple Subcisions on Rolling Acne Scars
Study Start Date : August 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Multiple Subcision
Subjects will receive multiple subcision treatments to their randomized side of the face 5 times total spaced 4 weeks apart.
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.

No Intervention: Control
Subjects will receive no intervention control on the other side of the face.

Primary Outcome Measures :
  1. Change in acne scarring compared to baseline after treatments [ Time Frame: Baseline and 36 weeks ]
    The change in acne scarring is measured using a quantitative global scarring grading system to compare baseline to the treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216864

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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Murad Alam, MD Northwestern University
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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02216864    
Other Study ID Numbers: STU97928
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases