CompletedNot Applicable

Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

United States29 participantsStarted 2015-11-12

Plain-language summary

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.

Who can participate

Age range20 Years – 60 Years

SexMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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:

What they're measuring

Patient Global Severity Assessment- Mechanics of Shaving

Timeframe: Baseline, 6 weeks

Trial details

NCT IDNCT03043534

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10-12

Results submitted2017-04-19

View on ClinicalTrials.gov More Pseudofolliculitis Barbae trials