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The Effect of Laser Hair Removal on Permanent Hair Reduction

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ClinicalTrials.gov Identifier: NCT00279643
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Jeffrey S. Orringer, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Laser Hair Removal in Healthy Subjects Procedure: Laser Hair Removal Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Laser Hair Removal on Markers of Follicular Stem Cells
Study Start Date : January 2005
Actual Study Completion Date : June 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Hair Removal

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 years or older of either gender.
  2. At least moderately dense axillary (armpit) hair that is dark (not blonde or white) in color.
  3. Subjects must understand and sign the informed consent documents prior to participation.
  4. Subjects must be in generally good health.
  5. Subjects must be willing and able to comply with the requirements of the protocol
  6. 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:

  1. Oral retinoid use within one year of study entry.
  2. History of prior laser therapy or electrolysis of the axillae.
  3. Subjects who do not desire permanent reduction in axillary hair.
  4. Non-compliant subjects.
  5. Pregnant or nursing subjects.
  6. Subjects with a significant medical history or concurrent illness/condition that the investigator(s) feel is not safe for study participation.
  7. Active infection of the site to be treated or a history of herpes simplex or zoster infection at the site to be treated.
  8. History of keloid scar formation.
  9. Known history of allergy or sensitivity to lidocaine.
  10. History of waxing, plucking, or bleaching of the hair for 6 weeks prior to the treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279643


Locations
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United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Study Chair: John J Voorhees, MD University of Michigan
More Information
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Responsible Party: Jeffrey S. Orringer, Professor of Dermatology, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT00279643    
Other Study ID Numbers: Derm 543
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Keywords provided by Jeffrey S. Orringer, University of Michigan:
Laser
immunohistochemical staining
Laser Hair Removal
follicular stem cells
keratin 15