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The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris; a randomized controlled clinical trial.

Title
The efficacy and safety of oral low dose naltrexone versus placebo in the patients with lichen planopilaris; a randomized controlled clinical trial.
Publication Type
Journal Article
Research Type
Human
Reported as
Clinical Trial
Date
May 23, 2020
Authors
Vahideh Lajevardi, Fereshteh Salarvand, Maryam Ghiasi,Maryam Nasimi, Mohammad Taraz
Institution
Tehran University of Medical Sciences
Link
Abstract

BACKGROUND: Lichen planopilaris (LPP) is one of the important causes of cicatricial alopecia. We aimed to evaluate the efficacy and safety of low-dose naltrexone (LDN) in the setting of a clinical trial in patients with LPP.

METHODS: We included patients with LPP between 2018 and 2020. Patients were allocated to two groups. The first group received topical clobetasol plus oral low dose naltrexone (3mg) while the second received topical clobetasol plus placebo. The assessment was made for the disease severity by lichen planopilaris activity index (LPPAI) instrument and the safety of the drug in 2-month intervals up to 6 months. To compare both groups, we used the ANOVA test for repeated measures.

RESULTS: Thirty-four patients were analyzed in intention-to-treat fashion. There was a decrescendo pattern on LPPAI scores that was statistically significant within the LDN (P = 0.001) but almost significant within the placebo group (P = 0.060) and non-significant between the groups (P = 0.813). The side effects attributable to the low dose naltrexone was not statistically different between studied groups.

CONCLUSION: Low dose naltrexone (3mg) failed to improve the severity of the LPP more than what is achievable with topical clobetasol.

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