Clinical trial NCT03569956: Shaving Satisfaction in Males With Skin Irritation From Shaving
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pseudofolliculitis Barbae
Keywords: Razor bumps
Skin Irritation
Shaving
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2018-06-26
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be divided into two groups: the Razor group of 20 subjects, and the Regimen group of 20 subjects. In the Razor group, subjects will use the 556 Razor with their regular shaving products, and shave at least 5 or more times per week. In the Regimen group, subjects will use the 556 Razor, Pre-Shave Gel, Cleansing brush and Shaving Gel, and shave at least 5 or more times per week. All subjects will be given the 556 Razors during the 12-week study. The Regimen group will also be given the Pre-Shave Gel, Cleansing Brush, and Shaving Gel.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Shaving Satisfaction and Appearance score
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Investigator Global Severity Assessment (IGA) score
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Disease severity assessed by lesion counts
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
measure: Patient's Global Severity Assessment (PGSA)- satisfaction of shaving experience
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Patient's Global Severity Assessments- skin irritation
timeFrame: Baseline, Week 4, Week 8, Week 12
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy J McMichael, MD
role: PRINCIPAL_INVESTIGATOR
References: