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NCT04409041 · ClinicalTrials.gov registry record · Phase 2
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT04409041 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 43 participants.
The verdict
NCT04409041, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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.
Interventions
- DRUG Low-Dose Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04409041
The ClinicalTrials.gov registry entry for NCT04409041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Low-Dose Naltrexone is the first listed.
NCT04409041 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04409041 about?
NCT04409041 is a clinical study titled "Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia". 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 plan...
What is the current status of trial NCT04409041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2019-09-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT04409041?
The interventions under investigation include: Low-Dose Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04409041?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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