NCT04403282

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 27, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

May 21, 2020

Last Update Submit

January 29, 2024

Conditions

Pseudofolliculitis Barbae

Keywords

Pseudofolliculitis BarbaeEflornithine

Outcome Measures

Primary Outcomes (1)

  • number of skin lesions

    number of skin lesions

    16 weeks

Secondary Outcomes (1)

  • number of hairs

    16 weeks

Study Arms (2)

Paired(right and left neck) comparison group eflornithine

ACTIVE COMPARATOR

randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.

Drug: Eflornithine Topical

Paired(right and left neck) comparison group placebo

PLACEBO COMPARATOR

randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.

Drug: Placebo Eflornithine Topical

Interventions

Eflornithine TopicalDRUG

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

Paired(right and left neck) comparison group eflornithine
Placebo Eflornithine TopicalDRUG

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

Paired(right and left neck) comparison group placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Active Duty Service Members with Pseudofolliculitis Barbae

You may not qualify if:

  • Previous treatment with laser hair removal in the previous 12 months, Currently pregnant, seeking pregnancy, or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Related Publications (4)

  • Alexander AM, Delph WI. Pseudofolliculitis barbae in the military. A medical, administrative and social problem. J Natl Med Assoc. 1974 Nov;66(6):459-64, 479. No abstract available.

    PMID: 4436875BACKGROUND

  • Gelman AB, Norton SA, Valdes-Rodriguez R, Yosipovitch G. A review of skin conditions in modern warfare and peacekeeping operations. Mil Med. 2015 Jan;180(1):32-7. doi: 10.7205/MILMED-D-14-00240.

    PMID: 25562855BACKGROUND

  • Ogunbiyi A. Pseudofolliculitis barbae; current treatment options. Clin Cosmet Investig Dermatol. 2019 Apr 16;12:241-247. doi: 10.2147/CCID.S149250. eCollection 2019.

    PMID: 31354326BACKGROUND

  • Xia Y, Cho S, Howard RS, Maggio KL. Topical eflornithine hydrochloride improves the effectiveness of standard laser hair removal for treating pseudofolliculitis barbae: a randomized, double-blinded, placebo-controlled trial. J Am Acad Dermatol. 2012 Oct;67(4):694-9. doi: 10.1016/j.jaad.2011.10.029. Epub 2012 Jan 9.

    PMID: 22226431BACKGROUND

MeSH Terms

Conditions

pseudofolliculitis barbae

Interventions

Eflornithine

Intervention Hierarchy (Ancestors)

OrnithineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Diamino

Study Officials

  • Sunghun Cho, MD

    Walter Reed National Military Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: randomized, double-blinded, placebo-controlled, paired (right and left neck) comparison study examining eflornithine versus placebo for the treatment of PFB.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

September 27, 2020

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

The PI will compile the names of the patients who are followed through week 16 in order to create the master subject list. Using the information stored on the master subject list (name, social security number, Medical Record Number), the research team will obtain data electronically from the patient medical records. Specifically, the lesion and hair counts on the face will be acquired. This will be recorded on the master data sheet. The master subject list will be password protected and only accessible to study personnel within the Walter Reed National Military Medical Center (WRNMMC) network. The master data sheet will be coded and available to the investigators and may be shared with research assistants or statisticians.

Locations

US(1)