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Treatment of Acne Scarring With a Novel Procedure Combination

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT00510055
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
25
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.

Condition or Disease Intervention/Treatment Phase
  • Procedure: subdermal manipulation ONLY
  • Procedure: subdermal manipulation AND injection of a filler
 N/A

Detailed Description

The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

scars receive subdermal manipulation ONLY

Procedure: subdermal manipulation ONLY
scars receive subdermal manipulation ONLY
Other Names:
  • subcision

    		•
    Experimental: B

    scars receive subdermal manipulation AND injection of a filler

    Procedure: subdermal manipulation AND injection of a filler
    scars receive subdermal manipulation AND injection of a filler
    Other Names:
  • Radiesse

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Scar Improvement [3.5 months]

    Secondary Outcome Measures

    1. Adverse Events [3.5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 18 and over

    • Have two acne scar areas

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Feinberg School of Medicine, Department of Dermatology Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Murad Alam, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT00510055
    Other Study ID Numbers:
    • STU752
    First Posted:
    Aug 1, 2007
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Cicatrix

    Study Results

    No Results Posted as of Dec 2, 2021