N/A N=29 Randomized Single-blind Treatment

Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

Pseudofolliculitis Barbae

Bottom Line

View on ClinicalTrials.gov: NCT03043534 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Patient Global Severity Assessment- Mechanics of Shaving — 12.9; 12.4; 8.5; 9.7 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: shave gel (Other); Brush (Other)
Age: Adult · 20+ yrs
Sex: Male
Sponsor: Wake Forest University Health Sciences
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Global Severity Assessment- Mechanics of Shaving	12.9; 12.4; 8.5; 9.7	—
SECONDARY Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)	2.33; 2.64; 1.46; 1.85	—
SECONDARY Quality of Life Survey	24.6; 23.5; 13; 11.4; 12; 11.4	—
SECONDARY Lesions	23.7; 20.3; 19.4; 16.1	—
SECONDARY Investigator Global Assessment (IGA)	2.73; 2.57; 2.06; 2.26	—

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.

Eligibility Criteria

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:
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03043534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.