NCT03240627

Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Legacy Healthcare SA · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Methods / trial design: Randomised, double-blind, vehicle-controlled multicentre trial in parallel groups. At screening (Visit 0), subjects will discontinue their previous treatment for alopecia areata, if any. Screening period will last up to 28 days. The 24-week treatment phase will include assessment Visits 1 to 3, which will take place at 12-week intervals. At assessment Visit 1, eligible subjects will be randomly assigned in a 2:1 ratio to receive LH-8 cutaneous solution or vehicle (placebo) twice daily for a 24 week treatment period. During the treatment phase the subjects will complete daily their drug diaries. The post-treatment safety and efficacy follow-up phase will include Visit 4 and Visit 5, 12 and 24 weeks after end of treatment, respectively. Subjects (as applicable) and parents will be instructed to contact the investigator, if an event on scalp (intolerance) occurs during the treatment or post-treatment period. They may be asked to come to the site for an unscheduled visit, in order to perform additional examinations.

Conditions

• Alopecia Areata
• Pediatric Disorder

Interventions

Type	Name	Description
DRUG	LH-8	LH-8 cutaneous solution
DRUG	Placebo	Placebo cutaneous solution

Timeline

• Start date: 2018-02-01
• Primary completion: 2022-03-14
• Completion: 2022-09-14
• First posted: 2017-08-07
• Last updated: 2023-12-12

Locations

3 sites across 3 countries: Bulgaria, France, Germany