Clinical trial NCT03043534: Pre-Shave Gel and Brush in Pseudofolliculitis Barbae
Official title: The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pseudofolliculitis Barbae
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 29
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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

Eligibility criteria: Inclusion Criteria:

1. Males with at least a two year history of the symptoms of PFB.
2. Must be age 20-60 years of age (inclusive).
3. 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.
4. Must have Mild -to moderate PFB based on IGA rating scales. There are no lesion count inclusion requirements.

Exclusion Criteria:

1. Use of systemic (oral antibiotics) within the last 4 weeks.
2. 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.
3. Individuals who do not wet shave with a bladed razor, or who use electric shavers.
4. Subjects must not have used any type of cleansing or shave brush to the face for six weeks prior to Baseline.
5. Individuals who have removed a beard within last two months.
6. Individuals who have a history of alopecia areata of the face.
7. 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

Primary outcomes:
measure: Patient Global Severity Assessment- Mechanics of Shaving
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
timeFrame: Baseline, 6 weeks
measure: Quality of Life Survey
timeFrame: Baseline, 6 weeks
measure: Lesions
timeFrame: Baseline, 6 weeks
measure: Investigator Global Assessment (IGA)
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dept of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy McMIchael, MD
role: PRINCIPAL_INVESTIGATOR
References: