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NCT Number: NCT03569956

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pseudofolliculitis Barbae

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Disease severity assessed by lesion counts

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

    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.

Other outcomes

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

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

    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.

  2. Change in Patient's Global Severity Assessments- skin irritation

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

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Procter and Gamble

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2026
First posted
Jun 26, 2018
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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