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

Frontal Fibrosing Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409041
• Other study ID #: 201908021
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Frontal Fibrosing Alopecia
• Lichen Planopilaris
• Lichen Planus

Intervention

Drug:
• Low-Dose Naltrexone
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.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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