Back to resultsMagic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae
Primary Purpose
Pseudofolliculitis Barbae
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Magic Shave Powder Gold
Traditional Shaving Methods
Sponsored by
About this trial
This is an interventional prevention trial for Pseudofolliculitis Barbae
Eligibility Criteria
Inclusion Criteria:
- Male
- PFB patient
Exclusion Criteria:
- Failed sensitivity testing
Sites / Locations
- Wayne State University Physician Group Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Magic Shave Powder Gold
Traditional Methods
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04220502
Brief Title
Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae
Official Title
Depilatory Cream's Affect on the Occurrence of Pseudofolliculitis Barbae
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the amount of papules, macules, pustules, and irritation caused by pseudofolluculitis barbae in subjects using depilatory cream versus traditional shaving methods.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudofolliculitis Barbae
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Comparing an experimental to control group
Masking
Investigator
Masking Description
Single blinded study where investigator does not know what method of facial hair removal subjects have used
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magic Shave Powder Gold
Arm Type
Experimental
Arm Description
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
Arm Title
Traditional Methods
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Magic Shave Powder Gold
Other Intervention Name(s)
Experimental
Intervention Description
Depilatory Cream for facial hair removal
Intervention Type
Device
Intervention Name(s)
Traditional Shaving Methods
Other Intervention Name(s)
Control
Intervention Description
Continued facial hair removal using traditional razors
Primary Outcome Measure Information:
Title
Investigator Global Assessment
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient Global Assessment
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
PFB patient
Exclusion Criteria:
Failed sensitivity testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Daveluy, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University Physician Group Dermatology
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23652888
Citation
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.
Results Reference
background
PubMed Identifier
21916277
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.
Results Reference
result
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Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae
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