NCT00279643

Brief Summary

The purpose of this study is to learn more about how hair removal with lasers achieves, what appears to be, permanent hair reduction. Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about how the permanent reduction in the treated areas occurs. Recently, it has been discovered that certain cells in the hair follicle must be destroyed in order to achieve permanent hair reduction. A marker of these types of cells known as keratin 15 has been identified. By measuring the amount of keratin 15 before and after laser therapy, we hope to gain a better understanding of how lasers cause hair reduction on a biochemical level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

First QC Date

January 17, 2006

Last Update Submit

April 29, 2015

Conditions

Keywords

Laserimmunohistochemical stainingLaser Hair Removalfollicular stem cellskeratin 15

Outcome Measures

Primary Outcomes (1)

  • measurement of the effects of laser hair removal on the immunohistochemical staining properties of human hair follicles, including the putative stem cells of the bulge region.

Secondary Outcomes (1)

  • Hair Removal

Interventions

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older of either gender.
  • At least moderately dense axillary (armpit) hair that is dark (not blonde or white) in color.
  • Subjects must understand and sign the informed consent documents prior to participation.
  • Subjects must be in generally good health.
  • Subjects must be willing and able to comply with the requirements of the protocol
  • 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 use within one year of study entry.
  • History of prior laser therapy or electrolysis of the axillae.
  • Subjects who do not desire permanent reduction in axillary hair.
  • Non-compliant subjects.
  • Pregnant or nursing subjects.
  • Subjects with a significant medical history or concurrent illness/condition that the investigator(s) feel is not safe for study participation.
  • Active infection of the site to be treated or a history of herpes simplex or zoster infection at the site to be treated.
  • History of keloid scar formation.
  • Known history of allergy or sensitivity to lidocaine.
  • History of waxing, plucking, or bleaching of the hair for 6 weeks prior to the treatment.

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

Study Officials

  • John J Voorhees, MD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dermatology, Medical School

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

January 1, 2005

Study Completion

June 1, 2006

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations