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CompletedNCT00279643Updated Apr 30, 2015

The Effect of Laser Hair Removal on Permanent Hair Reduction

A Phase 1/2 interventional study of Laser Hair Removal in Laser Hair Removal in Healthy Subjects, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-30.

Sponsored by University of Michigan · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Laser Hair Removal in Healthy Subjects

Keywords

  • Laser
  • immunohistochemical staining
  • Laser Hair Removal
  • follicular stem cells
  • keratin 15
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants

Interventions

  • ProcedureLaser Hair Removal
06

What researchers measure

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

07

Study locations

1 site
  • University of Michigan Department of Dermatology
    Ann Arbor, Michigan 48109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00279643
Lead sponsor
University of Michigan
Responsible party
Jeffrey S. Orringer (Professor of Dermatology, Medical School, University of Michigan) — Principal investigator
First posted
Jan 19, 2006
Start date
Jan 2005
Completion
Jun 2006
Last update
Apr 30, 2015

Study contacts

John J Voorhees, MD
study chair · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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