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

Primary Purpose

Pseudofolliculitis Barbae

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudofolliculitis Barbae focused on measuring Ethnic Skin, Laser, Photobiology, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Naval Medical Center San Diego

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2006
Last Updated
November 20, 2006
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00402129
Brief Title
Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI
Official Title
Clinical Safety and Efficacy of Prototype Devices for Hair Growth Control: Task 2.4
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudofolliculitis Barbae
Keywords
Ethnic Skin, Laser, Photobiology, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.
Primary Outcome Measure Information:
Title
Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.
Secondary Outcome Measure Information:
Title
In addition, hair and papule counts were performed on a subset of five patients.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Victor Ross, MD
Organizational Affiliation
Scripps Green Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

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

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