Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

Phase 2

Completed

• Conditions: Alopecia Areata; Pediatric Disorder
• Interventions: Drug: LH-8; Drug: Placebo

• Registration Number: NCT03240627
• Lead Sponsor: Legacy Healthcare SA

Brief 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.

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2018-02-01
• Primary Completion: 2022-03-14
• Study Completion: 2022-09-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-12-09
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LH-8 cutaneous solution	LH-8	LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp:
Placebo cutaneous solution	Placebo	Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp:

Primary Outcome Measures

Name	Time	Method
Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment.	24 weeks treatment	Visual assessment and global standardised scalp photographs for SALT evaluation.

Secondary Outcome Measures

Name	Time	Method
Absolute change in SALT score from baseline at the end of 24 weeks' treatment period.	24 weeks treatment
Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period.	24 weeks treatment
Adverse events	48 weeks
Visual assessment and global standardised scalp photographs for SALT evaluation.	After 12 and 24 weeks treatment	Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)
Change in percentage of subjects from baseline by the severity banding CDLQI scores.	48 weeks
Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5.	48 weeks
General physical examination findings, including irritation of eyes and skin	24 weeks treatment
Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas.	24 weeks treatment
Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline	48 weeks
Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5.	48 weeks
Assessment of the rate of spontaneous hair regrowth.	For 6-12 months	Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation).
• Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores.	48 weeks

Trial Locations

Locations (3)

Centre Sabourand - Hospital Saint-Louis, 1, Avenue Claude Vellefaux; 🇫🇷 Paris, France

Multicenter Clinical Trials; 🇧🇬 Sofia, Bulgaria

Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin; 🇩🇪 Berlin, Berlin,, Germany