Shaving Satisfaction in Males With Skin Irritation From Shaving

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03569956
• Other study ID #: IRB00051291
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Pseudofolliculitis Barbae

Intervention

Other:
• 556 Razor
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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

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