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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in Shaving Satisfaction and Appearance score
Study Overview
Brief Summary
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.
Detailed Description
A secondary objective is to show improvement in the satisfaction of the shaving experience, symptoms such as bumps and irritation, and quality of life (QOL), when adding the 556 Razor, or the 556 Razor with a regimen of pre-shave gel, cleansing brush, and shave gel to the shaving regimen of males with shaving skin irritation. Shaving irritation severity will be correlated to shave satisfaction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males with at least a two year history of the symptoms of skin irritation from shaving.
- •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 shave at least 5 times per week during the study
- •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
- •Changes in the use of systemic (oral antibiotics) within the last 4 weeks. Stable use of oral antibiotics for any condition are allowed
- •Changes in the use of topical prescriptions
- •Individuals who do not wet shave with a bladed razor, or who use electric shavers.
- •Individuals who have removed a beard within last two months.
Arms & Interventions
Razor Group
Subject will use the 556 razor with regular shaving products, and shave at least 5 or more times per week
Intervention: 556 Razor (Other)
Regimen
Subject will use the 556 razor with the Pre-shave Gel, Cleaning Brush, and Shaving Gel and shave at least 5 or more times per week.
Intervention: 556 Razor (Other)
Outcomes
Primary Outcomes
Change in Shaving Satisfaction and Appearance score
Time Frame: Baseline, Week 4, Week 8, Week 12
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.
Change in Investigator Global Severity Assessment (IGA) score
Time Frame: Baseline, Week 4, Week 8, Week 12
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.
Secondary Outcomes
- Disease severity assessed by lesion counts(Baseline, Week 4, Week 8, Week 12)