Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00402129
Status:
COMPLETED
Last Update Posted:
2006-11-22
First Post:
2006-11-20
Brief Title:
Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV V VI
Sponsor:
United States Naval Medical Center San Diego
Organization:
United States Naval Medical Center San Diego
Study Overview
Official Title:
Clinical Safety and Efficacy of Prototype Devices for Hair Growth Control Task 24
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NdYAG 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 Jcm2 for a normal bearded subject produce significant discomfort Blistering and subsequent pigmentary changes have been reported in patients with type V-VI skin7 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 NdYAG laser using a fluence of 12Jcm2 in patients with PFB and Fitzpatrick skin types IV V and VI
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 NdYAG 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 Jcm2 for a normal bearded subject produce significant discomfort Blistering and subsequent pigmentary changes have been reported in patients with type V-VI skin7 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 NdYAG laser using a fluence of 12Jcm2 in patients with PFB and Fitzpatrick skin types IV V and VI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None