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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Lichen Planopilaris; Frontal Fibrosing Alopecia

Treatments: Drug: Low-Dose Naltrexone

Study type: Interventional

Funder types: Other

Identifiers

NCT04409041

201908021

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Low-dose naltrexone group

Experimental group

Description:

All participants were prescribed low-dose naltrexone at 3mg oral daily.

Treatment:

Drug: Low-Dose Naltrexone