Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

NCT03043534 | Completed Results

• 1 other identifier: IRB00034479
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudofolliculitis Barbae

Outcome Measures

Primary Outcomes (1)

• Patient Global Severity Assessment- Mechanics of Shaving

  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? For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics

  Baseline, 6 weeks

Secondary Outcomes (4)

• Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)

  Baseline, 6 weeks

• Quality of Life Survey

  Baseline, 6 weeks

• Lesions

  Baseline, 6 weeks

• Investigator Global Assessment (IGA)

  Baseline, 6 weeks

Study Arms (2)

Gel and Brush

EXPERIMENTAL

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.

Other: shave gel; Other: Brush

Control

NO INTERVENTION

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

Interventions

shave gel 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

Gel and Brush

Brush OTHER

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

Also known as: Oil of Olay cleansing brush

Gel and Brush

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: les with psuedofolliculitis barbae
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences Dept of Dermatology

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

pseudofolliculitis barbae

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Results Point of Contact

• Title: Dr Amy McMichael
• Organization: WakeForest

amcmicha@wakehealth.edu

336-716-3775

Study Officials

• Amy McMIchael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 6, 2017
• Study Start: November 12, 2015
• Primary Completion: October 12, 2016
• Study Completion: October 12, 2016
• Last Updated: December 19, 2018
• Results First Posted: July 2, 2017

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)