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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04220502
Other study ID # WayneMed
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date August 1, 2020
Est. completion date May 3, 2022

Study information

Verified date May 2022
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Comparing an experimental group that will remove facial hair with magic shave powder gold, and a control group that will continue using traditional shaving methods. Both the subject and a physician will make observations to determine the efficacy of depilatory creams in reducing pseudofolliculits barbae.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 3, 2022
Est. primary completion date May 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male - PFB patient Exclusion Criteria: - Failed sensitivity testing

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magic Shave Powder Gold
Depilatory Cream for facial hair removal
Device:
Traditional Shaving Methods
Continued facial hair removal using traditional razors

Locations

Country Name City State
United States Wayne State University Physician Group Dermatology Dearborn Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patient Global Assessment Difference in the investigator assessment of disease symptoms at baseline and 12 weeks, measured by patient. The scale title is Patient Global Assessment, the minimum value is 0, the maximum is 5. Higher scores mean worse outcome. 12 weeks
See also
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Terminated NCT04403282 - Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial Phase 4
Active, not recruiting NCT03569956 - Shaving Satisfaction in Males With Skin Irritation From Shaving N/A
Completed NCT04993066 - Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro Plus N/A
Completed NCT03043534 - Pre-Shave Gel and Brush in Pseudofolliculitis Barbae N/A
Completed NCT00176995 - Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae Phase 2
Completed NCT00402129 - Low Fluence 1064nm Laser Hair Reduction for Pseudofolliculitis Barbae in Skin Types IV, V, VI N/A