Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial

NCT04403282 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-01-31

No results posted yet for this study

Summary

To study the efficacy of topical eflornithine for pseudofolliculitis barbae from a quality of life standpoint and with objective physician-measured lesion counts. Our hypothesis is that the hair growth retardation that occurs with eflornithine will perhaps reduce the frequency over time that service members need to shave which could improve the formation of PFB lesions.

Conditions

  • Pseudofolliculitis Barbae

Interventions

DRUG

Eflornithine Topical

Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.

DRUG

Placebo Eflornithine Topical

Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Sunghun Cho, MD · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-27
Primary Completion
2023-06-22
Completion
2023-06-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403282 on ClinicalTrials.gov