Pseudofolliculitis Barbae Clinical Trial
Official title:
The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae
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.
This will be a randomized investigator blinded study of up to 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. The study gel and brush will be used prior to their normal shave
routine.Quantitative lesion counts will be done by trained clinicians at each visit. Efficacy
assessments include Investigator Global Assessment (IGA) scoring
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