Microdermabrasion for Acne - Full Text View

Sponsor:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00355485

Purpose

The purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. The microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well microdermabrasion works to improve the symptoms of acne.

Condition	Intervention	Phase
Acne Vulgaris	Device: microdermabrasion	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Microdermabrasion for Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Counts of specific types of acne lesions. [ Time Frame: These lesions will be counted at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical photographs [ Time Frame: Photographs may be obtained at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks. ] [ Designated as safety issue: No ]
Subject self-assessment questionnaire [ Time Frame: At end of treatment phase. ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Device: Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.

Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart.

Detailed Description:

Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.

Microdermabrasion is a technique combining abrasion and negative pressure used primarily in the treatment of aging skin. It has also been proposed to improve acne presumably through a comedolytic effect. Negative pressure and abrasion may remove debris from follicular orifices that act as a nidus for acne lesions. Many physicians and spas use micordermabrasion as a treatment for acne, however, there has never been a randomized controlled trial to substantiate this practice.

We propose to evaluate the efficacy of microdermabrasion in the treatment of inflammatory acne. We will use the Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 13 years or older of either gender and of any racial/ethnic group.
Presence of clinically evident acne vulgaris of the facial skin.
Subjects must be in generally good health.
Subjects must be able and willing to comply with the requirements of the protocol.
Subjects must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

Oral retinoid use within 6 months of entry into the study.
Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
Topical acne therapies (retinoids,antibiotics) within 2 weeks of entry into the study.
Laser or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
Non-compliant subjects.
Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
Subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study.
Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
Pregnant or nursing females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355485

Locations

United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

Study Chair:	John J Voorhees, MD	University of Michigan
Principal Investigator:	Darius Karimipour, MD	University of Michigan

More Information

No publications provided

Responsible Party:	University of Michigan Department of Dermatology ( Darius J. Karimipour, M.D., Clinical Assistant Professor )
Study ID Numbers:	Derm 563
Study First Received:	July 21, 2006
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00355485 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Acne
Microdermabrasion

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions
Sebaceous Gland Diseases
Acne Vulgaris

ClinicalTrials.gov processed this record on February 08, 2010