---
title: Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
nct_id: NCT04409041
overall_status: COMPLETED
phase: PHASE2
sponsor: Washington University School of Medicine
study_type: INTERVENTIONAL
primary_condition: Lichen Planopilaris
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04409041.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04409041"
ct_last_update_post_date: 2021-12-30
last_seen_at: "2026-05-12T06:20:47.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia

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

**NCT ID:** [NCT04409041](https://clinicaltrials.gov/study/NCT04409041)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 43
- **Lead Sponsor:** Washington University School of Medicine
- **Conditions:** Lichen Planopilaris, Frontal Fibrosing Alopecia
- **Start Date:** 2019-09-01
- **Completion Date:** 2020-12-31
- **CT.gov Last Update:** 2021-12-30

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Low-dose naltrexone group** (EXPERIMENTAL) — All participants were prescribed low-dose naltrexone at 3mg oral daily.

## Interventions

- **Low-Dose Naltrexone** (DRUG) — 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.

## Primary Outcomes

- **Change in Patient-Reported Itch** _(time frame: 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** _(time frame: 12 months)_ — 0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months.
- **Patient Reported Burning/Pain** _(time frame: 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 Investigator Rated Scale** _(time frame: 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.

## Locations (1)

- Washington University, St Louis, Missouri, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.washington university|st louis|missouri|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04409041.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04409041*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*