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

Overview

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 9 months to monitor their progress.

Full Title of Study: “Oral Low-Dose Naltrexone in the Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia; an Uncontrolled Open-label Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Drug: Low-Dose Naltrexone
    • 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 9months to monitor their progress.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Patient-Reported Itch/Burn
    • Time Frame: At baseline and every 3 months for total 9 months.
    • 0/10 scale for itch/burn
  • Change in Investigator Rated Erythema/Scale
    • Time Frame: At baseline and every 3 months for total 9 months.
    • 0-3 scale for erythema/scale
  • Change in Progression of Hair Loss
    • Time Frame: At baseline and every 3 months for total 9 months.
    • measurement of hair loss (cm)

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor

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