Microdermabrasion for Acne

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

microdermabrasion

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne, Microdermabrasion

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microdermabrasion Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Counts of specific types of acne lesions.

Secondary Outcome Measures

Clinical photographs

Subject self-assessment questionnaire

Full Information

NCT ID

NCT00355485

First Posted

July 21, 2006

Last Updated

July 8, 2015

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00355485

Brief Title

Microdermabrasion for Acne

Official Title

Microdermabrasion for Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne, Microdermabrasion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microdermabrasion Treatment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

microdermabrasion

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

Title

Subject self-assessment questionnaire

Time Frame

At end of treatment phase.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John J Voorhees, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Darius Karimipour, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Department of Dermatology

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Acne Vulgaris

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial