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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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 ap
Sponsor: United States Naval Medical Center, San Diego

Current Primary Outcome: Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: United States Naval Medical Center, San Diego

Dates:
Date Received: November 20, 2006
Date Started: January 2006
Date Completion: May 2006
Last Updated: November 20, 2006
Last Verified: November 2006