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Treatment of Acne Scarring With a Novel Procedure Combination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00510055
First received: July 31, 2007
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance

Resource links provided by NLM:

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

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Scar Improvement [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 31, 2007
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
 Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013