- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279643
The Effect of Laser Hair Removal on Permanent Hair Reduction
The Effect of Laser Hair Removal on Markers of Follicular Stem Cells
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about the mechanisms involved in achieving what clinically appears to be permanent reduction in hair density in treated areas. We postulate that in order to achieve permanent hair reduction, stem cells located in the bulge region of the follicle must be destroyed. Recently, a marker of follicular stem cells (keratin 15) has been identified and noted to be detectable using immunohistochemical techniques. In addition, several other immunohistochemical markers for various components of the hair follicle are available.
We propose to quantitatively measure the effects of laser hair removal on the immunohistochemical staining properties of treated follicles with respect to keratin 15 and other follicular markers. We hypothesize that the degree of such staining will be greatly reduced following laser therapy, thus providing, to our knowledge, the first biochemical evidence to support permanence of the treatment's effects.
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Hair Removal
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Derm 543
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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