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Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

NCT03240627 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2023-12-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LH-8

LH-8 cutaneous solution

DRUG

Placebo

Placebo cutaneous solution

Sponsors & Collaborators

  • Legacy Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Ulrike BLUME-PEYTAVI, Prof. Dr. · Charité-Universitätsmedizin Berlin, Dept Dermatology, Germany

  • Pascal REYGAGNE, Dr. · Sabouraud Center, Saint-Louis Hospital, France

  • Petyo Brezoev, Dr. · DDC Alexandrovska-Sofia", Bulgaria

  • Uwe Schwichtenberg, Dr. · Hautarztpraxis, Bremen-Vegesack, Germany

  • Maya Milanova, Dr · Center of Skin and venereal diseases, Sliven, Bulgaria

  • Mariyana Venelinova_Rusinova, Dr · MC Doverie, Sofia, Bulgaria

  • Ishad Aggarwal, Dr · Health Point Hospital 21, Kolkata, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Bulgaria
  • France
  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03240627 on ClinicalTrials.gov