Pseudofolliculitis BarbaeNCT00402129
Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI
A study testing 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size. in people with Pseudofolliculitis Barbae, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
To report the safety and efficacy of 1064nm low fluence laser hair reduction for the treatment of pseudofolliculitis barbae Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudofolliculitis Barbae
- What is being tested?
- 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: 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
Read the 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.
- Conditions
- Pseudofolliculitis Barbae
- Being tested
- 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.
- Keywords
- Ethnic Skin, Laser, Photobiology, Quality of life
- Medical subject headings
- pseudofolliculitis barbae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.
Secondary outcomes (1)
In addition, hair and papule counts were performed on a subset of five patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startJan 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pseudofolliculitis BarbaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Investigators
- E. Victor Ross, MD, Principal investigator, Scripps Green Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402129
- Sponsor's protocol ID
- CIP#S-05-121
- Status last verified
- Nov 2006
- First submitted
- 20 Nov 2006
- Last updated
- 22 Nov 2006
- Results posted
- No
Publications
Alajlan A, Shapiro J, Rivers JK, MacDonald N, Wiggin J, Lui H. Paradoxical hypertrichosis after laser epilation. J Am Acad Dermatol. 2005 Jul;53(1):85-8. doi: 10.1016/j.jaad.2004.06.054.
PubMed 15965427Alster TS, Bryan H, Williams CM. Long-pulsed Nd:YAG laser-assisted hair removal in pigmented skin: a clinical and histological evaluation. Arch Dermatol. 2001 Jul;137(7):885-9.
PubMed 11453807Bronner AK, Hood AF. Cutaneous complications of chemotherapeutic agents. J Am Acad Dermatol. 1983 Nov;9(5):645-63. doi: 10.1016/s0190-9622(83)70177-5.
PubMed 6643764Garcia-Zuazaga J. Pseudofolliculitis barbae: review and update on new treatment modalities. Mil Med. 2003 Jul;168(7):561-4.
PubMed 12901468Guardiano RA, Norwood CW. Direct comparison of EMLA versus lidocaine for pain control in Nd:YAG 1,064 nm laser hair removal. Dermatol Surg. 2005 Apr;31(4):396-8. doi: 10.1111/j.1524-4725.2005.31104.
PubMed 15871313Lanigan SW. Incidence of side effects after laser hair removal. J Am Acad Dermatol. 2003 Nov;49(5):882-6. doi: 10.1016/s0190-9622(03)02106-6.
PubMed 14576669Lim SP, Lanigan SW. A review of the adverse effects of laser hair removal. Lasers Med Sci. 2006 Sep;21(3):121-5. doi: 10.1007/s10103-006-0377-y. Epub 2006 Jul 1.
PubMed 16816888Orringer JS, Hammerberg C, Lowe L, Kang S, Johnson TM, Hamilton T, Voorhees JJ, Fisher GJ. The effects of laser-mediated hair removal on immunohistochemical staining properties of hair follicles. J Am Acad Dermatol. 2006 Sep;55(3):402-7. doi: 10.1016/j.jaad.2006.04.057. Epub 2006 May 26.
PubMed 16908343Rohrer TE, Chatrath V, Yamauchi P, Lask G. Can patients treat themselves with a small novel light based hair removal system? Lasers Surg Med. 2003;33(1):25-9. doi: 10.1002/lsm.10192.
PubMed 12866118Ross EV, Cooke LM, Overstreet KA, Buttolph GD, Blair MA. Treatment of pseudofolliculitis barbae in very dark skin with a long pulse Nd:YAG laser. J Natl Med Assoc. 2002 Oct;94(10):888-93.
PubMed 12408693Ross EV, Cooke LM, Timko AL, Overstreet KA, Graham BS, Barnette DJ. Treatment of pseudofolliculitis barbae in skin types IV, V, and VI with a long-pulsed neodymium:yttrium aluminum garnet laser. J Am Acad Dermatol. 2002 Aug;47(2):263-70. doi: 10.1067/mjd.2002.124081.
PubMed 12140474Ross EV, Ladin Z, Kreindel M, Dierickx C. Theoretical considerations in laser hair removal. Dermatol Clin. 1999 Apr;17(2):333-55, viii. doi: 10.1016/s0733-8635(05)70091-7.
PubMed 10327301Weaver SM 3rd, Sagaral EC. Treatment of pseudofolliculitis barbae using the long-pulse Nd:YAG laser on skin types V and VI. Dermatol Surg. 2003 Dec;29(12):1187-91. doi: 10.1111/j.1524-4725.2003.29387.x.
PubMed 14725660Weinstein GD, Mooney KM. Cell proliferation kinetics in the human hair root. J Invest Dermatol. 1980 Jan;74(1):43-6. doi: 10.1111/1523-1747.ep12514601.
PubMed 7351493
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety and Efficacy of Prototype Devices for Hair Growth Control: Task 2.4
- ClinicalTrials.gov ID
- NCT00402129
- Acronym / sponsor ID
- CIP#S-05-121
- Conditions
- Pseudofolliculitis Barbae
- Keywords
- Ethnic Skin, Laser, Photobiology, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Jan 2006
- Study completion
- May 2006
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size. | Procedure or surgery | – |
Primary outcome
Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.
1 secondary outcome
In addition, hair and papule counts were performed on a subset of five patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2006.
- Background: PubMed 15965427Alajlan A, Shapiro J, Rivers JK, MacDonald N, Wiggin J, Lui H. Paradoxical hypertrichosis after laser epilation. J Am Acad Dermatol. 2005 Jul;53(1):85-8. doi: 10.1016/j.jaad.2004.06.054.
- Background: PubMed 11453807Alster TS, Bryan H, Williams CM. Long-pulsed Nd:YAG laser-assisted hair removal in pigmented skin: a clinical and histological evaluation. Arch Dermatol. 2001 Jul;137(7):885-9.
- Background: PubMed 6643764Bronner AK, Hood AF. Cutaneous complications of chemotherapeutic agents. J Am Acad Dermatol. 1983 Nov;9(5):645-63. doi: 10.1016/s0190-9622(83)70177-5.
- Background: PubMed 12901468Garcia-Zuazaga J. Pseudofolliculitis barbae: review and update on new treatment modalities. Mil Med. 2003 Jul;168(7):561-4.
- Background: PubMed 15871313Guardiano RA, Norwood CW. Direct comparison of EMLA versus lidocaine for pain control in Nd:YAG 1,064 nm laser hair removal. Dermatol Surg. 2005 Apr;31(4):396-8. doi: 10.1111/j.1524-4725.2005.31104.
- Background: PubMed 14576669Lanigan SW. Incidence of side effects after laser hair removal. J Am Acad Dermatol. 2003 Nov;49(5):882-6. doi: 10.1016/s0190-9622(03)02106-6.
- Background: PubMed 16816888Lim SP, Lanigan SW. A review of the adverse effects of laser hair removal. Lasers Med Sci. 2006 Sep;21(3):121-5. doi: 10.1007/s10103-006-0377-y. Epub 2006 Jul 1.
- Background: PubMed 16908343Orringer JS, Hammerberg C, Lowe L, Kang S, Johnson TM, Hamilton T, Voorhees JJ, Fisher GJ. The effects of laser-mediated hair removal on immunohistochemical staining properties of hair follicles. J Am Acad Dermatol. 2006 Sep;55(3):402-7. doi: 10.1016/j.jaad.2006.04.057. Epub 2006 May 26.
- Background: PubMed 12866118Rohrer TE, Chatrath V, Yamauchi P, Lask G. Can patients treat themselves with a small novel light based hair removal system? Lasers Surg Med. 2003;33(1):25-9. doi: 10.1002/lsm.10192.
- Background: PubMed 12408693Ross EV, Cooke LM, Overstreet KA, Buttolph GD, Blair MA. Treatment of pseudofolliculitis barbae in very dark skin with a long pulse Nd:YAG laser. J Natl Med Assoc. 2002 Oct;94(10):888-93.
- Background: PubMed 12140474Ross EV, Cooke LM, Timko AL, Overstreet KA, Graham BS, Barnette DJ. Treatment of pseudofolliculitis barbae in skin types IV, V, and VI with a long-pulsed neodymium:yttrium aluminum garnet laser. J Am Acad Dermatol. 2002 Aug;47(2):263-70. doi: 10.1067/mjd.2002.124081.
- Background: PubMed 10327301Ross EV, Ladin Z, Kreindel M, Dierickx C. Theoretical considerations in laser hair removal. Dermatol Clin. 1999 Apr;17(2):333-55, viii. doi: 10.1016/s0733-8635(05)70091-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Victor Ross, MD principal investigator
Scripps Green Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064nm Nd:YAG laser at 12 J/cm2, 20 ms and 10mm spot size. in people with Pseudofolliculitis Barbae, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of PFB by assessing dyspigmentation, papule counts and cobblestoning.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402129, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2006; AzTrials last refreshed its copy on 8 Nov 2026.