NCT00355485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

July 21, 2006

Last Update Submit

July 8, 2015

Conditions

Acne Vulgaris

Keywords

AcneMicrodermabrasion

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • 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.

  • Subject self-assessment questionnaire

    At end of treatment phase.

Study Arms (1)

Microdermabrasion Treatment

EXPERIMENTAL

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

Interventions

microdermabrasionDEVICE

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.

Microdermabrasion Treatment

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • John J Voorhees, MD

    University of Michigan

    STUDY CHAIR

  • Darius Karimipour, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 24, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

US(1)