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Treatment of Acne Scarring With a Novel Procedure Combination

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ClinicalTrials.gov Identifier: NCT00510055
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):

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
Acne Scarring Procedure: subdermal manipulation ONLY Procedure: subdermal manipulation AND injection of a filler

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  (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
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
U.S. FDA Resources

Arms and Interventions

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
United States, Illinois
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
More Information

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00510055     History of Changes
Other Study ID Numbers: STU752
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes