Treatment of Acne Scarring With a Novel Procedure Combination - Full Text View

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00510055

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
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 ]

Estimated Enrollment:	20
Study Start Date:	June 2007
Estimated Study Completion Date:	October 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental scars receive subdermal manipulation ONLY	Procedure: subdermal manipulation ONLY scars receive subdermal manipulation ONLY
B: Experimental 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

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, Suite 1600
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University, Feinberg School of Medicine, Department of Dermatology

More Information

No publications provided

Responsible Party:	Northwestern University ( Murad Alam, MD )
Study ID Numbers:	STU00000752
Study First Received:	July 31, 2007
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00510055 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions

Sebaceous Gland Diseases
Acne Vulgaris
Cicatrix

ClinicalTrials.gov processed this record on November 25, 2009