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

Phase 2

Completed

• Conditions: Lichen Planopilaris; Frontal Fibrosing Alopecia
• Interventions: Drug: Low-Dose Naltrexone

• Registration Number: NCT04409041
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Results First Submitted: 2021-10-21
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Results First Posted: 2021-12-30
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-dose naltrexone group	Low-Dose Naltrexone	All participants were prescribed low-dose naltrexone at 3mg oral daily.

Primary Outcome Measures

Name	Time	Method
Patient Reported Burning/Pain	12 months	Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months.
Change in Patient-Reported Itch	12 months	0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months.
Change in Investigator Rated Erythema	12 months	0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months.
Change in Investigator Rated Scale	12 months	Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States