Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04409041
Status:
COMPLETED
Last Update Posted:
2021-12-30
First Post:
2020-05-22
Brief Title:
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Oral Low-Dose Naltrexone in the Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia an Uncontrolled Open-label Prospective Study
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mgday At lower doses of 1-5mgday 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 036 and 12 months to monitor their progress
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 036 and 12 months to monitor their progress
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None