Shaving Satisfaction in Males With Skin Irritation From Shaving

NCT03569956 | Active Not Recruiting

• 1 other identifier: IRB00051291
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudofolliculitis Barbae

Keywords

Razor bumps; Skin Irritation; Shaving

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Disease severity assessed by lesion counts

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (2)

• Patient's Global Severity Assessment (PGSA)- satisfaction of shaving experience

  Baseline, Week 4, Week 8, Week 12

• Change in Patient's Global Severity Assessments- skin irritation

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Razor Group

ACTIVE COMPARATOR

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

Other: 556 Razor

Regimen

EXPERIMENTAL

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

Interventions

556 Razor OTHER

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.

Razor Group; Regimen

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Procter and Gamble: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

pseudofolliculitis barbae

Study Officials

• Amy J McMichael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: October 29, 2018
• Primary Completion: April 30, 2019
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)