556 Razor for Razor Bumps

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Electric shavers, Recent beard removal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how the 556 Razor, a new razor technology, can enhance shaving experiences and reduce skin irritation and razor bumps. Participants are divided into two groups: one using only the razor, and another using the razor with additional products like a pre-shave gel and cleansing brush. Men who have experienced skin irritation from shaving for at least two years and wet shave with a blade at least three times a week may qualify for this study. The researchers aim to determine if these new shaving methods can significantly benefit those struggling with razor bumps. As an unphased trial, this study provides a unique opportunity to explore innovative shaving solutions and potentially improve daily routines.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on stable oral antibiotics, you can continue using them.

What prior data suggests that this razor technology is safe for shaving?

Research shows that people using similar razors often report mild and temporary skin irritation, such as redness and bumps, commonly known as razor bumps. These bumps occur because shaved hair can curl back into the skin, causing irritation. However, these effects are usually mild and resolve on their own.

Since this trial is in an early phase, researchers are still studying the safety of the specific 556 Razor. If it resembles other razors on the market, it is likely to be well-tolerated, with any side effects being mild and short-lived. If irritation occurs, it might resemble the typical effects of shaving, which often improve over time or with proper skincare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 556 Razor treatment for razor bumps because it offers a unique approach compared to standard shaving methods. Unlike traditional razors, the 556 Razor is paired with a comprehensive regimen that includes a Pre-shave Gel, Cleaning Brush, and Shaving Gel, which may enhance the shaving experience by preparing and protecting the skin more effectively. This combination aims to reduce irritation and prevent the development of razor bumps more efficiently. The potential for this regimen to deliver smoother skin with fewer bumps and irritation is what sets it apart and sparks interest in its potential benefits.

What evidence suggests that this trial's treatments could be effective for razor bumps?

This trial will compare two different uses of the 556 Razor for reducing razor bumps and improving skin quality in people with pseudofolliculitis barbae (PFB). Studies have shown that the 556 Razor can significantly reduce razor bumps and enhance skin quality. For men with PFB, using this razor at least five times a week for 12 weeks led to noticeable improvements in skin appearance and overall quality of life. Specifically, a small study found that the SkinGuard technology in the razor reduced PFB bumps by more than 61% after three months. This suggests that the 556 Razor could effectively reduce shaving-related skin irritation and improve overall satisfaction with shaving. ^{4 6 7 8 9}

Who Is on the Research Team?

Amy McMichael, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

Individuals who do not wet shave with a bladed razor, or who use electric shavers

I have recently changed my prescription skin treatments.

I haven't changed my oral antibiotic use in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the 556 razor with regular shaving products or with a regimen including pre-shave gel, cleansing brush, and shaving gel

12 weeks

Baseline, Week 4, Week 8, Week 12

Follow-up

Participants are monitored for changes in shaving satisfaction and skin irritation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 556 Razor

Trial Overview 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.

How Is the Trial Designed?

Group I: Regimen Experimental Treatment 1 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 Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Procter and Gamble

Industry Sponsor

Trials

150

Recruited

77,000+

Marc Pritchard

Procter and Gamble

Chief Marketing Officer since 2008

B.S. in Finance from Indiana University, Bloomington

Jon R. Moeller

Procter and Gamble

Chief Executive Officer since 2021

MBA from Cornell University, B.S. in Biology from Cornell University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03569956

Shaving Satisfaction in Males With Skin Irritation From ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36735974/

New Razor Technology Improves Appearance and Quality ... In men with PFB, shaving with the test razor at least 5 times per week over a 12-week period improved the appearance and QOL of males with razor bumps and ...

3. community.the-hospitalist.org community.the-hospitalist.org/content/new-razor-technology-improves-appearance-and-quality-life-men-pseudofolliculitis-barbae

New Razor Technology Improves Appearance and Quality ... Shaving every other day for 1 week with the manual razor resulted in more papule formation but less irritation than use of the depilatories. The ...

4. malacards.org malacards.org/card/pseudofolliculitis_barbae

Pseudofolliculitis Barbae (PFB) Pseudofolliculitis barbae is a common hair disorder primarily affecting curly haired males in the facial and submental regions after regular shaving.

5. dermatologytimes.com dermatologytimes.com/view/small-study-shows-razor-technology-reduces-pseudofolliculitis-barbae

Small study shows razor technology reduces ... A 12-week study shows its SkinGuard razor reduced incidence of pseudofolliculitis barbae papules in men by more than 61% at three months.

6. dermnetnz.org dermnetnz.org/topics/pseudofolliculitis-barbae

Pseudofolliculitis Barbae (Razor Bumps) Also known as “razor bumps” or “shaving bumps”, it can also occur on any site where hair is shaved or plucked, including the axilla, pubic area, and legs.

7. skinsight.com skinsight.com/skin-conditions/pseudofolliculitis-barbae/

Razor Bumps (Pseudofolliculitis Barbae) Severe pseudofolliculitis barbae can lead to small bumps and sometimes scarring, as seen here. In pseudofolliculitis barbae (also called razor ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6585396/

Pseudofolliculitis barbae; current treatment options - PMC PFB is a chronic inflammatory disorder of follicular and perifollicular skin characterized by papules, pustules, and post-inflammatory hyperpigmentation.

9. uspharmacist.com uspharmacist.com/article/pseudofolliculitis-barbae-prevention-and-treatment

Pseudofolliculitis Barbae: Prevention and Treatment Pseudofolliculitis barbae (PFB), also known informally as razor bumps, is a common, chronic, inflammatory skin condition that occurs as a result of shaving.