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OpenTrials
Completed

NCT Number: NCT04409041

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 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.

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Key information

Conditions

Lichen Planopilaris Frontal Fibrosing Alopecia Lichen Planus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University

St Louis, Missouri, 63141, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2020
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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