Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI

November 20, 2006 updated by: United States Naval Medical Center, San Diego

Clinical Safety and Efficacy of Prototype Devices for Hair Growth Control: Task 2.4

To report the safety and efficacy of 1064nm low fluence laser hair reduction for the treatment of pseudofolliculitis barbae

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pseudofolliculitis barbae (PFB) is an acneiform eruption of the bearded area usually seen in dark-skinned individuals with thick, tightly curled hair. Typically, the hair shafts curve back directly into adjacent skin or the shaft penetrates through the follicular epithelium into the superficial dermis. The subsequent foreign body inflammatory reaction leads to discomfort, pigment alteration, infection, scarring and a potential decreased ability to shave. PFB continues to be a significant problem in the military with tremendous cost to the US Government, both in direct treatment of the condition as well as indirectly due to the loss of man-hours in personnel training, clinic visits, and ultimately, administrative separation.

Chemical depilatories, topical corticosteroids, topical retinoids, topical antibiotics, and eflornithine hydrochloride cream are helpful in the management of PFB. Growing a beard is usually curative; however in the military a clean shaven face is required. Since 1984, the US Navy has not allowed the wearing of beards, noting that facial hair may interfere with the proper fitting of protective gear used against biochemical warfare agents, or in the case of oxygen mask or breathing apparatus. In refractory cases, permanent laser hair removal with the long-pulse Nd:YAG has been shown to decrease the severity of PFB in dark skinned individuals. This wavelength is safe, effective, and due to its increased penetration, allows for increased ratio of hair bulb to epidermal heating in patients with Fitzpatrick skin type IV through VI.

Traditional 1064nm laser fluences (defined here as 22-40 J/cm2) for a normal bearded subject produce significant discomfort. Blistering and subsequent pigmentary changes have been reported in patients with type V-VI skin.7 Patients often require topical anesthesia with prolonged application times, ranging from 45 to 90 minutes. Treatments are usually scheduled every four to six weeks and in the military, these are conducted by trained physicians at major treatment facilities. Theoretically, the aim of the 1064nm laser treatment is long lasting or permanent hair reduction via conductive thermal diffusion causing lethal damage to the hair bulb and bulge area from the melanosome-containing hair shaft and matrix. However, in patients treated at the highest possible fluence eventually become symptomatic within 12 to 18 months of their final treatment.

The purpose of this study was to determine if PFB could be mitigated with a weekly treatment protocol. We evaluated a1064nm Nd:YAG laser using a fluence of 12J/cm2 in patients with PFB and Fitzpatrick skin types IV, V and VI.

Study Type

Interventional

Enrollment

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • active duty males/females, 18 years of age or older, Fitzpatrick skin types IV to VI, and all presented with a pseudofolliculitis barbae as determined by one of the dermatologists participating in the study

Exclusion Criteria:

  • history of vitiligo, photosensitivity, keloids, or herpes simplex in the treatment area, or any chronic medical conditions that may impair wound healing, such as diabetes mellitus and collagen vascular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.

Secondary Outcome Measures

Outcome Measure
In addition, hair and papule counts were performed on a subset of five patients.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, San Diego

Investigators

  • Principal Investigator: E. Victor Ross, MD, Scripps Green Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

November 22, 2006

Last Update Submitted That Met QC Criteria

November 20, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP#S-05-121

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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