Microdermabrasion for Acne

Acne Vulgaris Clinical Trial

Official title:

Microdermabrasion for Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355485
• Other study ID #: Derm 563
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2006
• Last updated: July 8, 2015
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Department of Dermatology	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Counts of specific types of acne lesions.		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.	No
Secondary	Clinical photographs		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.	No
Secondary	Subject self-assessment questionnaire		At end of treatment phase.	No