Microdermabrasion for Acne

• ClinicalTrials.gov Identifier: NCT00355485
• Recruitment Status: Completed
• First Posted: July 24, 2006
• Last Update Posted: July 10, 2015
• Sponsor: University of Michigan
• Information provided by: University of Michigan

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Acne Vulgaris	Device: microdermabrasion	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Microdermabrasion for Acne Vulgaris
• Study Start Date: September 2006
• Actual Primary Completion Date: July 2007
• Actual Study Completion Date: July 2007

Arms and Interventions

Arm

Intervention/treatment

Experimental: Microdermabrasion Treatment; Bilateral, split-face comparison in which one half of the face will be randomly assigned to receive the microdermabrasion treatment(s) while the other half of the face will not. Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart. In all cases, microdermabrasion treatment parameters will be within those accepted in cosmetic work.

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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]

Secondary Outcome Measures :

1. 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. ]
2. Subject self-assessment questionnaire [ Time Frame: At end of treatment phase. ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Darius J. Karimipour, M.D., Clinical Assistant Professor, University of Michigan Department of Dermatology
• ClinicalTrials.gov Identifier: NCT00355485
• Other Study ID Numbers: Derm 563
• First Posted: July 24, 2006
• Last Update Posted: July 10, 2015
• Last Verified: July 2015

Keywords provided by University of Michigan:

Acne; Microdermabrasion

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases