Clinical Trial: Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae

Brief 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.


Detailed Summary:

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


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Patient global severity [ Time Frame: 6 weeks ]

Patient's Global Severity Assessment (Degree of Itching, Burning and Stinging) based on the following scale:

Please indicate how much immediate post shave itching/burning/stinging you are experiencing at this time on a scale of 1 to 5 (circle one):

  1. = No itching/burning/stinging at all
  2. = Mild or minimal itching/burning/stinging
  3. = Moderate itching/burning/stinging
  4. = Severe itching/burning/stinging
  5. = Very severe (maximum itching/burning/stinging)


Original Primary Outcome: Same as current

Current Secondary Outcome: Mechanics of shaving [ Time Frame: 6 weeks ]

A total of the Patient's Global Assessment of mechanics of shaving based on following scale:

How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)

A) get a smooth shave after shaving? __________

B) shave stubborn hairs? __________

C) shave against the grain with little irritation? __________

D) shave with the grain with little irritation? __________

E) glide comfortably over your skin with the razor blade?



Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: January 31, 2017
Date Started: November 12, 2015
Date Completion:
Last Updated: February 14, 2017
Last Verified: February 2017