Microdermabrasion for Acne

July 8, 2015 updated by: University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
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.
Subject self-assessment questionnaire
Time Frame: At end of treatment phase.
At end of treatment phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Darius Karimipour, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 21, 2006

First Submitted That Met QC Criteria

July 21, 2006

First Posted (Estimate)

July 24, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Derm 563

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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