Pseudofolliculitis Barbae Clinical Trial
Official title:
The Impact of the 556 Razor Technology and of a Regimen of the 556 Razor Technology With Pre-Shave Gel and Brush on Shaving Satisfaction in Males With Skin Irritation From Shaving
Verified date | May 2024 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to evaluate the improvement in overall shave satisfaction, the appearance of skin irritation from shaving, and the razor related inflammation of the hair follicles when using a new razor technology in a regular shaving regimen as well as a new razor technology in a shaving regimen that includes a pre-shave gel, cleansing brush and shaving gel.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | August 2024 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Males with at least a two year history of the symptoms of skin irritation from shaving. 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 shave at least 5 times per week during the study 4. Must have Mild to moderate symptoms of skin irritation from shaving based on IGA rating scales. There must be the presence of some razor bumps but there are no lesion count inclusion requirements. Exclusion Criteria: 1. Changes in the use of systemic (oral antibiotics) within the last 4 weeks. Stable use of oral antibiotics for any condition are allowed 2. Changes in the use of topical prescriptions 3. Individuals who do not wet shave with a bladed razor, or who use electric shavers. 4. Individuals who have removed a beard within last two months. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient's Global Severity Assessment (PGSA)- satisfaction of shaving experience | Change in the satisfaction of Shaving experience by subjects completing the patients's global severity assessment during the 12 week study. The score range is 0-30. The lower the scores, the better the outcome. | Baseline, Week 4, Week 8, Week 12 | |
Other | Change in Patient's Global Severity Assessments- skin irritation | Change in skin irritation will be evaluated by subjects by completing the patients's global severity assessment during the 12 week study. The score range is 0-30. The lower the scores, the better the outcome. | Baseline, Week 4, Week 8, Week 12 | |
Primary | Change in Shaving Satisfaction and Appearance score | Shaving Satisfaction and Appearance will be captured by the subject during 12 week time frame to document changes in severity and appearance and assessed by the Patient Global Severity Assessment. The score range is 0-30. The lower the scores; the better the outcome. | Baseline, Week 4, Week 8, Week 12 | |
Primary | Change in Investigator Global Severity Assessment (IGA) score | Disease severity will be assessed Investigator Global Severity Assessment (IGA). Appearance will be captured by the PI by using a scale 0 (clear) to 5 (very severe) during the 12 week time frame to document changes in severity and appearance. The score range is 0-5. The lower the scores, the better the outcome. | Baseline, Week 4, Week 8, Week 12 | |
Secondary | Disease severity assessed by lesion counts | Disease severity will be assessed by lesion counts of any follicular papules in the beard area (not including acne) pustules, excoriations, hyperpigmentation, and ingrown hairs. Higher scores are indicative of worse outcome because more lesions mean more involvement of the razor bumps and associated inflammation. | Baseline, Week 4, Week 8, Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04403282 -
Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04993066 -
Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus
|
N/A | |
Completed |
NCT03043534 -
Pre-Shave Gel and Brush in Pseudofolliculitis Barbae
|
N/A | |
Completed |
NCT00176995 -
Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae
|
Phase 2 | |
Completed |
NCT00402129 -
Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI
|
N/A | |
Withdrawn |
NCT04220502 -
Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae
|
Early Phase 1 |