Pseudofolliculitis Barbae
Conditions
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
Interventions
OTHERshave 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
OTHERBrush
All subjects randomized to brush will use the brush with each shave
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Severity Assessment- Mechanics of Shaving | Baseline, 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Severity Assessment (Degree of Itching, Burning and Stinging) | Baseline, 6 weeks | 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 | Baseline, 6 weeks | 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 | Baseline, 6 weeks | Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation. |
| Investigator Global Assessment (IGA) | Baseline, 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Gel and Brush | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
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
Time frame: Baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gel and Brush | Patient Global Severity Assessment- Mechanics of Shaving | Baseline | 12.9 score on a scale | Standard Deviation 2.6 |
| Gel and Brush | Patient Global Severity Assessment- Mechanics of Shaving | Week 6 | 8.5 score on a scale | Standard Deviation 4.1 |
| Control | Patient Global Severity Assessment- Mechanics of Shaving | Baseline | 12.4 score on a scale | Standard Deviation 3.2 |
| Control | Patient Global Severity Assessment- Mechanics of Shaving | Week 6 | 9.7 score on a scale | Standard Deviation 4.8 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gel and Brush | Investigator Global Assessment (IGA) | Baseline | 2.73 units on a scale | Standard Deviation 0.79 |
| Gel and Brush | Investigator Global Assessment (IGA) | Week 6 | 2.06 units on a scale | Standard Deviation 1.38 |
| Control | Investigator Global Assessment (IGA) | Baseline | 2.57 units on a scale | Standard Deviation 0.75 |
| Control | Investigator Global Assessment (IGA) | Week 6 | 2.26 units on a scale | Standard Deviation 0.85 |
Secondary
Lesions
Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.
Time frame: Baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gel and Brush | Lesions | Baseline | 23.7 lesions | Standard Deviation 24.2 |
| Gel and Brush | Lesions | Week 6 | 19.4 lesions | Standard Deviation 18.5 |
| Control | Lesions | Baseline | 20.3 lesions | Standard Deviation 2.1 |
| Control | Lesions | Week 6 | 16.1 lesions | Standard Deviation 2.1 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gel and Brush | Patient Global Severity Assessment (Degree of Itching, Burning and Stinging) | Week 6 | 1.46 score on a scale | Standard Deviation 0.74 |
| Gel and Brush | Patient Global Severity Assessment (Degree of Itching, Burning and Stinging) | Baseline | 2.33 score on a scale | Standard Deviation 1.04 |
| Control | Patient Global Severity Assessment (Degree of Itching, Burning and Stinging) | Week 6 | 1.85 score on a scale | Standard Deviation 0.94 |
| Control | Patient Global Severity Assessment (Degree of Itching, Burning and Stinging) | Baseline | 2.64 score on a scale | Standard Deviation 1 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gel and Brush | Quality of Life Survey | Week 6 Social Interactions | 16.9 score on a scale | Standard Deviation 10.4 |
| Gel and Brush | Quality of Life Survey | Baseline Achieving Results | 12 score on a scale | Standard Deviation 4.88 |
| Gel and Brush | Quality of Life Survey | Baseline Social Interactions | 19.4 score on a scale | Standard Deviation 8.8 |
| Gel and Brush | Quality of Life Survey | Week 6 Achieving Results | 7.6 score on a scale | Standard Deviation 5.1 |
| Gel and Brush | Quality of Life Survey | Baseline Shaving Frustrations | 13 score on a scale | Standard Deviation 5.38 |
| Gel and Brush | Quality of Life Survey | Baseline Skin Feel | 13.2 score on a scale | Standard Deviation 4.6 |
| Gel and Brush | Quality of Life Survey | Baseline Skin-Confidence | 16.3 score on a scale | Standard Deviation 6.49 |
| Gel and Brush | Quality of Life Survey | Week 6 Shaving Experience | 12.5 score on a scale | Standard Deviation 6.24 |
| Gel and Brush | Quality of Life Survey | Week 6 Shaving Frustrations | 14.6 score on a scale | Standard Deviation 4.8 |
| Gel and Brush | Quality of Life Survey | Week 6 Skin Feel | 6.5 score on a scale | Standard Deviation 5 |
| Gel and Brush | Quality of Life Survey | Week 6 Self-Confidence | 10.8 score on a scale | Standard Deviation 6.5 |
| Gel and Brush | Quality of Life Survey | Baseline Shaving Experience | 24.6 score on a scale | Standard Deviation 10.3 |
| Control | Quality of Life Survey | Baseline Social Interactions | 17.8 score on a scale | Standard Deviation 5.6 |
| Control | Quality of Life Survey | Baseline Shaving Experience | 23.5 score on a scale | Standard Deviation 6.51 |
| Control | Quality of Life Survey | Baseline Shaving Frustrations | 11.4 score on a scale | Standard Deviation 2.59 |
| Control | Quality of Life Survey | Week 6 Self-Confidence | 10.3 score on a scale | Standard Deviation 5.2 |
| Control | Quality of Life Survey | Baseline Achieving Results | 11.4 score on a scale | Standard Deviation 4.55 |
| Control | Quality of Life Survey | Baseline Skin Feel | 10.7 score on a scale | Standard Deviation 4.59 |
| Control | Quality of Life Survey | Week 6 Shaving Experience | 20.5 score on a scale | Standard Deviation 6.5 |
| Control | Quality of Life Survey | Week 6 Shaving Frustrations | 9.9 score on a scale | Standard Deviation 2.9 |
| Control | Quality of Life Survey | Baseline Skin-Confidence | 13.9 score on a scale | Standard Deviation 5.2 |
| Control | Quality of Life Survey | Week 6 Achieving Results | 8.0 score on a scale | Standard Deviation 4 |
| Control | Quality of Life Survey | Week 6 Skin Feel | 8.5 score on a scale | Standard Deviation 4.6 |
| Control | Quality of Life Survey | Week 6 Social Interactions | 13.3 score on a scale | Standard Deviation 6.5 |