NCT00111254

Brief Summary

This research project aims to study the effects of microdermabrasion, a technique causing minimal injury used to improve the appearance of fine lines, wrinkles, and scars. Subjects will undergo microdermabrasion, which is a gentle "sand-blasting" of the skin. We are interested in determining how this procedure works at rebuilding the skin following microdermabrasion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 21, 2015

Status Verified

June 1, 2011

Enrollment Period

7.1 years

First QC Date

May 18, 2005

Last Update Submit

May 20, 2015

Conditions

Keywords

microdermabrasionskinwrinklescollagenphotoagingwrinkled skin

Outcome Measures

Primary Outcomes (1)

  • Observing changes over time with respect to the following biochemical endpoints: Procollagen I and III, matrix metalloproteinases (MMPs 1, 3, and 9), and several cytokines including Interleukins and Tumor Necrosis Factor.

    Group I: 1-4 weeks; Group II: 1-3 months

Secondary Outcomes (1)

  • Changes in clinical features associated with sun-damaged or wrinkled skin.

    Group I: 1-4 weeks, Group II: 1-3 months

Study Arms (2)

1

EXPERIMENTAL

In group I, acute effect group, each subject will undergo microdermabrasion of the hip/buttock. Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device). 4mm punch biopsies will be performed in the treated area at 4hrs, 8hrs, and 24hrs post-treatment. In addition, one 4mm punch biopsy will be obtained from adjacent untreated skin.

Procedure: Microdermabrasion

2

EXPERIMENTAL

In group II, chronic effect group, each subject will undergo microdermabrasion of the face at weekly intervals for six weeks. Treatment will consist of 3 passes in different directions with the microdermabrasion handpiece (horizontal, vertical, and oblique). Aluminum oxide abrasion and negative pressure will be increased as tolerated by the patient. Two 2mm punch biopsies will be obtained prior to the first treatment and one week following the sixth treatment.

Procedure: Microdermabrasion

Interventions

Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device).

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 or older
  • Patients must be available for follow up visits for biopsies to comply with the requirements of the protocol.
  • Patients must sign and understand the informed consent prior to participation in the study.
  • You 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 (vitamin-A like drugs) use within one year of entry into the study
  • Topical retinoid use within 3 months of the study
  • Patients with a history of excessive scarring
  • Patients with significant medical history or concurrent illness which investigators feel is not safe for study participation
  • Patients who have had any type of facial rejuvenation procedure or treatment (such as Botox injections, collagen implants, or chemical peels) within the past six months
  • Non-compliant patients
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Karimipour DJ, Rittie L, Hammerberg C, Min VK, Voorhees JJ, Orringer JS, Sachs DL, Hamilton T, Fisher GJ. Molecular analysis of aggressive microdermabrasion in photoaged skin. Arch Dermatol. 2009 Oct;145(10):1114-22. doi: 10.1001/archdermatol.2009.231.

Study Officials

  • John J Voorhees, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2005

First Posted

May 19, 2005

Study Start

June 1, 2002

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 21, 2015

Record last verified: 2011-06