The Effect of Laser Hair Removal on Permanent Hair Reduction

NCT ID: NCT00279643

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-06-30

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.

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.

Conditions

Laser Hair Removal in Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Laser Hair Removal

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey S. Orringer

Professor of Dermatology, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John J Voorhees, MD

Role: STUDY_CHAIR

University of Michigan

Locations

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Derm 543

Identifier Type: -

Identifier Source: org_study_id