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

This study has been completed.
Sponsor:
Information provided by:
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT00402129
First received: November 20, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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


Condition Intervention
Pseudofolliculitis Barbae
Procedure: 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Safety and Efficacy of Prototype Devices for Hair Growth Control: Task 2.4

Further study details as provided by United States Naval Medical Center, San Diego:

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.

Estimated Enrollment: 22
Study Start Date: January 2006
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402129

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: E. Victor Ross, MD Scripps Green Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00402129     History of Changes
Other Study ID Numbers: CIP#S-05-121
Study First Received: November 20, 2006
Last Updated: November 20, 2006
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
Ethnic Skin
Laser
Photobiology
Quality of life

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014