Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

Completed · Not applicable

Conditions studied: Pseudofolliculitis Barbae

In brief

This will be a randomized investigator blinded study of 40 men age 20-60 (inclusive) with symptoms of mild-moderate PFB based on Investigator Global Assessment (IGA). Subjects will be divided into two groups: the Control group of 20 subjects and the Experimental group of 20 Subjects. Subjects will be seen at Screening/Baseline, and 6 weeks. All subjects will use their normal razors and shave products during the six week study. The Experimental group of subjects will also be given the study product Pre-Shave Gel and Cleansing Brush.

Key facts

Study ID

NCT03043534

Run by

Wake Forest University Health Sciences

People needed

29

Starts

2015-11-12

Expected to finish

2016-10-12

Last updated by the study team

2018-12-19

Who can join

Age: 20 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males with at least a two year history of the symptoms of PFB.
• Must be age 20-60 years of age (inclusive).
• Must wet shave using just a prep and blade razor at least 3 or more times per week, and be willing to continue that regimen during the study.
• Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count inclusion requirements.

You may not qualify if…

• Use of systemic (oral antibiotics) within the last 4 weeks.
• Use of topical prescriptions (topical clindamycin, topical retinoids, topical metronidazole, topical sulfacetamide/sulfur, topical adapalene, benzoyl peroxide, salicylic acid, glycolic acid, retinol,chemical peels) or over-the-counter products the subject has used for PFB or Hair Growth within the last 2 weeks. Use of oral retinoids, laser therapy or electrolysis treatments or waxing in beard area in last 12 months.
• Individuals who do not wet shave with a bladed razor, or who use electric shavers.
• Subjects must not have used any type of cleansing or shave brush to the face for six weeks prior to Baseline.
• Individuals who have removed a beard within last two months.
• Individuals who have a history of alopecia areata of the face.
• Confounding dermatological conditions that would, in the opinion of the principal investigator, preclude participation in this study such as:
• Immune deficiency disease (HIV positive, AIDS, sarcoidosis)
• On immunosuppressive drugs (e.g. oral corticosteroids)
• Autoimmune disease (lupus, scleroderma, diabetes mellitus, vitiligo)
• Koebnerizing diseases (e.g. psoriasis, lichens planus, (HPV) human papilloma virus, facial verruca, molluscum contagiosum)
• Tuberculosis, Hepatitis B
• History of Keloids
• History of Herpes simplex in treated area
• Bacterial infection of face including abscesses and draining sinuses of facial area
• Cystic Acne, other acne in bearded area which interferes with shaving as well as the ability to distinguish PFB lesions from acne

Where it is running

• Wake Forest University Health Sciences Dept of Dermatology — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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