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556 Razor for Razor Bumps
N/A
Waitlist Available
Led By Amy J McMichael, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 20-60 years of age (inclusive)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, week 12
Awards & highlights
Study Summary
This trial is testing a new razor technology to see if it improves satisfaction with shaving, prevents skin irritation, and reduces inflammation of hair follicles.
Who is the study for?
This trial is for men aged 20-60 who wet shave with a blade at least three times weekly, are willing to shave five times per week during the study, and have mild to moderate skin irritation from shaving. Participants should have experienced these symptoms for two years but can't join if they've recently changed their use of oral antibiotics or topical prescriptions, don't usually wet shave with a blade, or have removed a beard in the last two months.Check my eligibility
What is being tested?
The study tests a new razor technology both alone and combined with additional shaving products like pre-shave gel and cleansing brush. It aims to assess improvements in overall satisfaction with shaving, reduction of skin irritation appearance, and inflammation caused by razors.See study design
What are the potential side effects?
While not explicitly mentioned here, potential side effects may include increased skin irritation or allergic reactions to any new product used as part of the trial's shaving regimen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 60 years old.
Select...
I currently shave 3+ times a week and am willing to shave 5 times a week for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 8, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Investigator Global Severity Assessment (IGA) score
Change in Shaving Satisfaction and Appearance score
Secondary outcome measures
Disease severity assessed by lesion counts
Other outcome measures
Change in Patient's Global Severity Assessments- skin irritation
Patient's Global Severity Assessment (PGSA)- satisfaction of shaving experience
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RegimenExperimental Treatment1 Intervention
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.
Group II: Razor GroupActive Control1 Intervention
Subject will use the 556 razor with regular shaving products, and shave at least 5 or more times per week
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,197 Total Patients Enrolled
Procter and GambleIndustry Sponsor
146 Previous Clinical Trials
76,540 Total Patients Enrolled
Amy J McMichael, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently changed my prescription skin treatments.I haven't changed my oral antibiotic use in the last 4 weeks.I have had skin irritation from shaving for at least two years.I experience mild to moderate skin irritation from shaving.I am between 20 and 60 years old.I currently shave 3+ times a week and am willing to shave 5 times a week for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Razor Group
- Group 2: Regimen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this trial limited to adults or is there a minimum age requirement?
"This trial has established age restrictions, with the minimal age for participation being 20 years old and a cap at 60."
Answered by AI
Are there any eligibility criteria for participation in this research?
"To be eligible for this clinical study, candidates must have pseudofolliculitis barbae with an age range of 20 to 60. As such, forty participants are currently being recruited."
Answered by AI
Is this research study currently enrolling participants?
"The clinical trial registry lists this medical study as not currently recruiting participants. The trial was first made public on October 29th 2018 and the most recent update occurred November 28th 2022. However, there is another related research effort which does require new enrollees at present."
Answered by AI
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