Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

Phase 2/3 Completed 107 enrolled Legacy Healthcare SA

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution versus placebo in children and adolescents with moderate to severe scalp alopecia areata. Phase 2/3 study performed in France, Germany, Bulgaria and India in 100 patients.

Timeline

Start: 2018-02-01
Primary completion: 2022-03-14
Completion: 2022-09-14

Outcome

Met primary endpoint

paper Cinainu showed significant benefits compared with placebo in relative change in SALT score from baseline to Week 24: PMID 40668972 ↗

paper relative change in SALT score from baseline to Week 24: adjusted mean difference [95% confidence interval CI)] + 26.3% (0.1-52.5); P = 0.0488 PMID 40668972 ↗

Publications

Blume-Peytavi U, Piraccini BM, Reygagne P, Guiraud J, Mukherjee B, Guichard A, Liu J, Pralong W, Harti S. Efficacy and safety of Cinainu in paediatric alopecia areata: an international, double-blind, randomized, placebo-controlled, phase II/III trial. Br J Dermatol. 2026 Jan 6;194(1):37-46. doi: 10.1093/bjd/ljaf279.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LH-8	Unknown	0.126 ml	Topical