Shaving Satisfaction in Males With Skin Irritation From Shaving

Not Applicable

Active, not recruiting

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Regimen	556 Razor	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.
Razor Group	556 Razor	Subject will use the 556 razor with regular shaving products, and shave at least 5 or more times per week

Primary Outcome Measures

Name	Time	Method
Change in Shaving Satisfaction and Appearance score	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	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 Outcome Measures

Name	Time	Method
Disease severity assessed by lesion counts	Baseline, Week 4, Week 8, Week 12	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.

Locations (1): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States

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