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

NCT04409041 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 201908021
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Lichen Planopilaris; Frontal Fibrosing Alopecia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Low-dose naltrexone group

EXPERIMENTAL

All participants were prescribed low-dose naltrexone at 3mg oral daily.

Drug: Low-Dose Naltrexone

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.

Low-dose naltrexone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Lichen Planus

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Caroline Mann
• Organization: Washington University

cmann@wustl.edu

(314) 996-8010

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 1, 2020
• Study Start: September 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 30, 2021
• Results First Posted: December 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)