Shaving Satisfaction in Males With Skin Irritation From Shaving
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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.
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| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Shaving Satisfaction and Appearance score [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 [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 Outcome Measures
- Disease severity assessed by lesion counts [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 Outcome Measures
- Patient's Global Severity Assessment (PGSA)- satisfaction of shaving experience [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.
- Change in Patient's Global Severity Assessments- skin irritation [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males with at least a two year history of the symptoms of skin irritation from shaving.
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Must be age 20-60 years of age (inclusive).
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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
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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:
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Changes in the use of systemic (oral antibiotics) within the last 4 weeks. Stable use of oral antibiotics for any condition are allowed
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Changes in the use of topical prescriptions
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Individuals who do not wet shave with a bladed razor, or who use electric shavers.
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Individuals who have removed a beard within last two months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- Procter and Gamble
Investigators
- Principal Investigator: Amy J McMichael, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00051291