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Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

Primary Purpose

Pseudofolliculitis Barbae

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
shave gel
Brush
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudofolliculitis Barbae

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences Dept of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gel and Brush

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.
Quality of Life Survey
Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures. For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures. For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures. For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures. For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures. For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.
Lesions
Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.

Full Information

First Posted
January 31, 2017
Last Updated
November 28, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03043534
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 12, 2015 (Actual)
Primary Completion Date
October 12, 2016 (Actual)
Study Completion Date
October 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudofolliculitis Barbae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gel and Brush
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
shave gel
Intervention Description
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
Intervention Name(s)
Brush
Other Intervention Name(s)
Oil of Olay cleansing brush
Intervention Description
All subjects randomized to brush will use the brush with each shave
Primary Outcome Measure Information:
Title
Patient Global Severity Assessment- Mechanics of Shaving
Description
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
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Description
Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.
Time Frame
Baseline, 6 weeks
Title
Quality of Life Survey
Description
Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures. For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures. For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures. For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures. For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures. For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures.
Time Frame
Baseline, 6 weeks
Title
Lesions
Description
Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
Time Frame
Baseline, 6 weeks
Title
Investigator Global Assessment (IGA)
Description
Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
les with psuedofolliculitis barbae
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy McMIchael, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Dept of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre-Shave Gel and Brush in Pseudofolliculitis Barbae

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