Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Primary Purpose
Lichen Planopilaris, Frontal Fibrosing Alopecia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low-Dose Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Planopilaris
Eligibility Criteria
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
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low-dose naltrexone group
Arm Description
All participants were prescribed low-dose naltrexone at 3mg oral daily.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04409041
First Posted
May 22, 2020
Last Updated
November 29, 2021
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04409041
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planopilaris, Frontal Fibrosing Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose naltrexone group
Arm Type
Experimental
Arm Description
All participants were prescribed low-dose naltrexone at 3mg oral daily.
Intervention Type
Drug
Intervention Name(s)
Low-Dose Naltrexone
Intervention Description
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 Outcome Measure Information:
Title
Change in Patient-Reported Itch
Description
0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months.
Time Frame
12 months
Title
Change in Investigator Rated Erythema
Description
0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months.
Time Frame
12 months
Title
Patient Reported Burning/Pain
Description
Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months.
Time Frame
12 months
Title
Change in Investigator Rated Scale
Description
Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
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