Shaving Satisfaction in Males With Skin Irritation From Shaving

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Pseudofolliculitis Barbae

Treatments: Other: 556 Razor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03569956

IRB00051291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Razor Group

Active Comparator group

Description:

Subject will use the 556 razor with regular shaving products, and shave at least 5 or more times per week

Treatment:

Other: 556 Razor

Regimen

Experimental group

Description:

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.

Treatment:

Other: 556 Razor