- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03043534
Pre-Shave Gel and Brush in Pseudofolliculitis Barbae
The Impact of a Pre-Shave Gel and Brush in Males With Pseudofolliculitis Barbae
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27104
- Wake Forest University Health Sciences Dept of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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
All subjects randomized to brush will use the brush with each shave
Other Names:
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Global Severity Assessment- Mechanics of Shaving
Time Frame: Baseline, 6 weeks
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)
Time Frame: Baseline, 6 weeks
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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.
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Baseline, 6 weeks
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Quality of Life Survey
Time Frame: Baseline, 6 weeks
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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. |
Baseline, 6 weeks
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Lesions
Time Frame: Baseline, 6 weeks
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Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
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Baseline, 6 weeks
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Investigator Global Assessment (IGA)
Time Frame: Baseline, 6 weeks
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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.
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Baseline, 6 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Amy McMichael, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00034479
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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