Microdermabrasion for Acne

NCT ID: NCT00355485

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-07-31

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.

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

microdermabrasion

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

University of Michigan Department of Dermatology

Principal Investigators

John J Voorhees, MD

Role: STUDY_CHAIR

University of Michigan

Darius Karimipour, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Derm 563

Identifier Type: -

Identifier Source: org_study_id