Topical Eflornithine for Pseudofolliculitis Barbae: RCT

Study Overview
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Brief Summary
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To study the efficacy of topical eflornithine for pseudofolliculitis barbae from a quality of life standpoint and with objective physician-measured lesion counts. Our hypothesis is that the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency over time that service members need to shave which could improve the formation of PFB lesions.

Detailed Description
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Pseudofolliculitis barbae (PFB), or 'ingrown hairs,' is a common skin disease of the face and neck caused by shaving in predisposed individuals who have naturally curly hair. It affects a disproportionate number of African American Service Members - up to 45% in one study.(Alexander, 1974) Keeping a close shave is a requirement for service in all of the Unites States armed services, and as a result, PFB is a major cause of morbidity in this population. The main rationale behind this policy is that a beard prevents a proper seal when using breathing protection devices, in particular gas masks. A review of various dermatologic conditions seen in wartime found that the incidence of PFB was 5.9% during the Vietnam War and 1.8% during Operation Iraqi Freedom (OIF) (Gelman, 2015). The authors argued that this was due to a relaxing of the shaving standards as part of the update PFB protocol followed during OIF. However, the United States Navy recently announced a change to their PFB protocol, discontinuing the issuance of permanent no-shave chits. Laser hair removal (LHR) using the Nd:YAG laser is the current treatment of choice for the majority of patients who fail conservative treatment with topical retinoids, antibiotics, and optimization of shaving practices. However, LHR treatment can induce a permanent change in facial hair density and patients treated with this modality may have to accept a permanent change in their ability to grow a beard. In addition, laser treatments have a potential for operative discomfort along with blistering and dyspigmentation of skin. Eflornithine is a topical medication that is FDA indicated for the treatment of unwanted terminal hairs in women. It works by its action as an irreversible inhibitor of ornithine decarboxylase, an enzyme responsible for the formation of polyamines which allow for various proliferative activities in the skin. It is the only known topical treatment that can retard the growth of human hair. Xia et al. showed that this medication can be used in conjunction with LHR to enhance the efficacy of the treatment for PFB(Xia, 2012). However, there are no studies to date that look at eflornithine as monotherapy for the treatment of PFB. The Unites States Navy has included topical eflornithine as a potential PFB treatment in their latest Bureau of Medicine and Surgery (BUMED) instruction despite the lack of evidence behind its use. If shown to be efficacious, this medication would provide a cost-effective treatment for PFB, especially in medical practices that do not have a hair removal laser. In addition, the effects of eflornithine are reversible with discontinuation, making it an ideal choice for patients and service members who would like to retain their ability to grow normal beards. Goal: To study the efficacy of topical eflornithine for pseudofolliculitis barbae from an objective physician-measured lesion count. Our hypothesis is that the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency over time that service members need to shave which could improve the formation of PFB lesions. Plan Recruitment of patients that meet inclusion criteria (No LHR treatments in the past year, Not pregnant or breast feeding). Provide written informed consent. Patients instructed to discontinue all other treatment modalities for PFB (plucking, waxing, chemical depilatories, topical retinoids). Patients receive two identical 30-g jars from the Walter Reed Army Medical Center research pharmacist. The jars will be labeled left and right and randomized by the pharmacy using a random number generator. Initial lesion counts and Skindex-16 QoL measurements taken. Two (left and right) 2-cm circles drawn at the junction of the submental chin and anterior neck for the lesion counts. Patients begin applying a thin layer of each cream corresponding to the site of application (left and right beard) twice a day. Follow up at 4 week intervals, at which the number of hairs and inflammatory papules will be counted within the two 2-cm circles on the submental chin by two dermatology residents or staff dermatologists. Patient then goes to research pharmacist. Pharmacist weighs both eflornithine as well as placebo cream to measure compliance. Re-issue new 30-g jars. At week 16, final lesions counts administered. Data is analyzed using Wilcoxon signed-rank tests. Findings published.

Official Title
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Topical Eflornithine Hydrochloride for Pseudofolliculitis Barbae: A Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Pseudofolliculitis Barbae

Intervention / Treatment
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* Drug: Eflornithine Topical
* Drug: Placebo Eflornithine Topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active Duty Service Members with Pseudofolliculitis Barbae Exclusion Criteria: Previous treatment with laser hair removal in the previous 12 months, Currently pregnant, seeking pregnancy, or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paired(right and left neck) comparison group eflornithine<br>randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB. | Drug: Eflornithine Topical<br>* Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.<br>|
| Placebo Comparator: Paired(right and left neck) comparison group placebo<br>randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB. | Drug: Placebo Eflornithine Topical<br>* Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of skin lesions | number of skin lesions | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hairs | number of hairs | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudofolliculitis Barbae, Eflornithine