Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia

Last updated: November 29, 2021
Sponsor: Washington University School of Medicine
Overall Status: Completed

Phase

2

Condition

Alopecia

Rash

Warts

Treatment

N/A

Clinical Study ID

NCT04409041
201908021
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. A recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. There were no reported adverse events.

Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults age 18 or greater
  • clinically or histologically confirmed diagnosis of lichen planopilaris or frontalfibrosing alopecia

Exclusion

Exclusion Criteria:

  • known allergy or hypersensitivity to naltrexone
  • patients with concurrent use of opioids
  • active depression, schizophrenia, and bipolar disorder

Study Design

Total Participants: 43
Study Start date:
September 01, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Washington University

    Saint Louis, Missouri 63141
    United States

    Site Not Available

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