Shaving Satisfaction in Males With Skin Irritation From Shaving

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pseudofolliculitis Barbae
• Intervention / Treatment: Other: 556 Razor

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Razor Group; Subject will use the 556 razor with regular shaving products, and shave at least 5 or more times per week	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Procter and Gamble
• Investigators: Principal Investigator: Amy J McMichael, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Shaving; Skin Irritation; Razor bumps
• Other Study ID Numbers: IRB00051291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No