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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lichen Planopilaris, Frontal Fibrosing Alopecia

Intervention / Treatment
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* Drug: Low-Dose Naltrexone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose naltrexone group<br>All participants were prescribed low-dose naltrexone at 3mg oral daily. | Drug: Low-Dose Naltrexone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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