Phase 2
N=43
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Lichen Planopilaris · Frontal Fibrosing Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT04409041 ↗Enrolled (actual)
43
Serious AEs
5.9%
Results posted
Dec 2021
Primary outcome: Primary: Change in Patient-Reported Itch — -0.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Low-Dose Naltrexone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-Reported Itch |
-0.33 | — |
| PRIMARY Change in Investigator Rated Erythema |
-0.93 | — |
| PRIMARY Patient Reported Burning/Pain |
-0.50 | — |
| PRIMARY Change in Investigator Rated Scale |
-0.33 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04409041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.