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

May 3, 2022 updated by: Steven D Daveluy, Wayne State University

Depilatory Cream's Affect on the Occurrence of Pseudofolliculitis Barbae

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Wayne State University Physician Group Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • PFB patient

Exclusion Criteria:

  • Failed sensitivity testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magic Shave Powder Gold
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
Depilatory Cream for facial hair removal
Other Names:
  • Experimental
Other: Traditional Methods
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
Continued facial hair removal using traditional razors
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Assessment
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Principal Investigator: Steven Daveluy, MD, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

May 3, 2022

Study Completion (Actual)

May 3, 2022

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WayneMed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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