Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

NCT ID: NCT03043534

Last Updated: 2018-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-12
• Study Completion Date: 2016-10-12

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

Conditions

Pseudofolliculitis Barbae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gel and Brush

The Experimental group of subjects will be given the study product Pre-Shave Gel and Brush. The gel and brush will be used prior to their normal shave routine. Subjects will shave at least 3 times weekly.

Group Type: EXPERIMENTAL

shave gel

Intervention Type: OTHER

Non marketed pre-shave gel with the following INCI list of ingredients:

WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE

Brush

Intervention Type: OTHER

All subjects randomized to brush will use the brush with each shave

Control

Subjects will use their normal razors and shave products during the six week study. Subjects must shave at least 3 times weekly. No change in normal shaving is done in this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

shave gel

Non marketed pre-shave gel with the following INCI list of ingredients:

WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE

Intervention Type: OTHER

Brush

All subjects randomized to brush will use the brush with each shave

Intervention Type: OTHER

Other Intervention Names

Oil of Olay cleansing brush

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy McMIchael, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dept of Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00034479

Identifier Type: -

Identifier Source: org_study_id