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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks |
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Inclusion Criteria:
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:
les with psuedofolliculitis barbae
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| Name | Affiliation | Role |
|---|---|---|
| Amy McMIchael, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Dept of Dermatology | Winston-Salem | North Carolina | 27104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 Brush: All subjects randomized to brush will use the brush with each shave |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 Brush: All subjects randomized to brush will use the brush with each shave |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 Brush: All subjects randomized to brush will use the brush with each shave |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Amy McMichael | WakeForest | 336-716-3775 | amcmicha@wakehealth.edu |
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| ID | Term |
|---|---|
| C563016 | pseudofolliculitis barbae |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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| Brush | Other | All subjects randomized to brush will use the brush with each shave |
|
|
| 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. |
| Baseline, 6 weeks |
| Lesions | Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation. | Baseline, 6 weeks |
| 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. | Baseline, 6 weeks |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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 |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
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|
|
| Secondary | Lesions | Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation. | Posted | Mean | Standard Deviation | lesions | Baseline, 6 weeks |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 weeks |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 | 0 | 14 | 0 | 14 | 0 | 14 |
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| Baseline Achieving Results |
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| Baseline Skin Feel |
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| Baseline Skin-Confidence |
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| Baseline Social Interactions |
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| Week 6 Shaving Experience |
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| Week 6 Shaving Frustrations |
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| Week 6 Achieving Results |
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| Week 6 Skin Feel |
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| Week 6 Self-Confidence |
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| Week 6 Social Interactions |
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