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Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

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ClinicalTrials.gov Identifier: NCT03043534
Recruitment Status : Completed
First Posted : February 6, 2017
Results First Posted : July 2, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


Condition or disease Intervention/treatment Phase
Pseudofolliculitis Barbae Other: shave gel Other: Brush Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae
Actual Study Start Date : November 12, 2015
Actual Primary Completion Date : October 12, 2016
Actual Study Completion Date : October 12, 2016

Arm Intervention/treatment
Experimental: 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.
Other: 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


Other: Brush
All subjects randomized to brush will use the brush with each shave
Other Name: Oil of Olay cleansing brush

No Intervention: 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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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?

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




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   les with psuedofolliculitis barbae
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043534


Locations
United States, North Carolina
Wake Forest University Health Sciences Dept of Dermatology
Winston-Salem, North Carolina, United States, 27104
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Amy McMIchael, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03043534     History of Changes
Other Study ID Numbers: IRB00034479
First Posted: February 6, 2017    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases