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Treatment of Acne Scarring With a Novel Procedure Combination

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: NCT00510055
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Study Description
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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
Acne Scarring Procedure: subdermal manipulation ONLY Procedure: subdermal manipulation AND injection of a filler Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
scars receive subdermal manipulation ONLY
 Procedure: subdermal manipulation ONLY
scars receive subdermal manipulation ONLY
Other Name: 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 Name: Radiesse


Outcome Measures
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Primary Outcome Measures :
  1. Scar Improvement [ Time Frame: 3.5 months ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 3.5 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT00510055


Locations
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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
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University
More Information
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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: August 1, 2007    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes