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Clinical Trials/NCT03569956
NCT03569956Active, not recruitingNot Applicable

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

Wake Forest University Health Sciences2 sites in 1 country40 target enrollmentStarted: October 29, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Locations
2
Primary Endpoint
Change in Shaving Satisfaction and Appearance score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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
  • 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

  • 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.

Arms & Interventions

Razor Group

Active Comparator

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

Intervention: 556 Razor (Other)

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.

Intervention: 556 Razor (Other)

Outcomes

Primary Outcomes

Change in Shaving Satisfaction and Appearance score

Time Frame: Baseline, Week 4, Week 8, Week 12

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.

Change in Investigator Global Severity Assessment (IGA) score

Time Frame: Baseline, Week 4, Week 8, Week 12

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.

Secondary Outcomes

  • Disease severity assessed by lesion counts(Baseline, Week 4, Week 8, Week 12)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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