Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae

NCT04220502 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: WayneMed
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the amount of papules, macules, pustules, and irritation caused by pseudofolluculitis barbae in subjects using depilatory cream versus traditional shaving methods.

Conditions

Pseudofolliculitis Barbae

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment

  Difference in the investigator assessment of lesions and irritation at baseline and 12 weeks, measured by investigator. The scale title is Investigator Global Assessment, the minimum value is 0, the maximum is 5. Higher scores mean worse outcome.

  12 weeks

Secondary Outcomes (1)

• Patient Global Assessment

  12 weeks

Study Arms (2)

Magic Shave Powder Gold

EXPERIMENTAL

This group will receive magic shaving powder gold and instructions on how to apply it. They will keep a log for their facial hair removal

Drug: Magic Shave Powder Gold

Traditional Methods

OTHER

This group will continue using traditional razors with the standard of care directions to shave. They will keep a log of their facial hair removal

Device: Traditional Shaving Methods

Interventions

Magic Shave Powder Gold DRUG

Depilatory Cream for facial hair removal

Also known as: Experimental

Magic Shave Powder Gold

Traditional Shaving Methods DEVICE

Continued facial hair removal using traditional razors

Also known as: Control

Traditional Methods

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• PFB patient

You may not qualify if:

• Failed sensitivity testing

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University Physician Group Dermatology

Dearborn, Michigan, 48124, United States

Location

Related Publications (2)

• Daniel A, Gustafson CJ, Zupkosky PJ, Candido A, Kemp HR, Russell G, McMichael A. Shave frequency and regimen variation effects on the management of pseudofolliculitis barbae. J Drugs Dermatol. 2013 Apr;12(4):410-8.

  PMID: 23652888 BACKGROUND

• Kindred C, Oresajo CO, Yatskayer M, Halder RM. Comparative evaluation of men's depilatory composition versus razor in black men. Cutis. 2011 Aug;88(2):98-103.

  PMID: 21916277 RESULT

MeSH Terms

Conditions

pseudofolliculitis barbae

Study Officials

• Steven Daveluy, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blinded study where investigator does not know what method of facial hair removal subjects have used
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of the American Academy of Dermatology

Model Details: Comparing an experimental to control group

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: August 1, 2020
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)