Microdermabrasion for Acne

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00355485
First received: July 21, 2006
Last updated: June 2, 2011
Last verified: June 2011

July 21, 2006
June 2, 2011
September 2006
January 2008   (final data collection date for primary outcome measure)
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 ]
Counts of specific types of acne lesions.
Complete list of historical versions of study NCT00355485 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical photographs
  • Subject self-assessment questionnaire
Not Provided
Not Provided
 
Microdermabrasion for Acne
Microdermabrasion for Acne Vulgaris

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
Device: microdermabrasion

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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00355485
Derm 563
No
Darius J. Karimipour, M.D., Clinical Assistant Professor, University of Michigan Department of Dermatology
University of Michigan
Not Provided
Study Chair: John J Voorhees, MD University of Michigan
Principal Investigator: Darius Karimipour, MD University of Michigan
University of Michigan
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP