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COMPLETEDPHASE2/PHASE3

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.

NCT03240627•Legacy Healthcare SA

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female children and adolescents aged 2 to less than 18 years with active alopecia areata involving 25% to 95% of the scalp between 6 months and 3 years in duration.
•Diagnosis and main criteria for inclusion: Male and female children and adolescents aged 2 to less than 18 years with active alopecia areata involving 25% to 95% of the scalp between 6 months and 3 years in duration.
•1. Male and female children and adolescents aged 2 to less than 18 years.
•2. Active scalp alopecia areata, involving 25% to 95% of the scalp (as measured by SALT score at screening).
•3. Duration of hair loss between 6 months and 3 years.
•4. Female subjects of childbearing potential (postmenarcheal) must have a negative urine pregnancy test at screening. Females of childbearing potential must either not be sexually active or be using an adequate birth control method throughout the duration of the study.
•5. All subjects taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
•6. Subjects must be willing to maintain the same hair style, including hair dye, throughout the study period.
•7. Written informed consent signed by parent(s) or legally authorized representative and assent or consent signed by the subjects, if applicable, according to national regulations prior to any protocol specific procedures.

Exclusion Criteria

•1. Hypersensitivity or intolerance to any active IMP substances (onion, citrus, caffeine, theobromine) or excipients (glycerine, betaine or ethanol).
•2. Any cause of hair loss other than alopecia areata.
•3. Active scalp inflammation except alopecia areata.
•4. Nevi, cutaneous or non-cutaneous lesions currently undiagnosed but suspicious for malignancy.
•5. Female adolescents who are pregnant or who are nursing or plan pregnancy during the trial period.
•6. Use of topical medication (listed in protocol Section 10.7.1) within 2 weeks prior to Visit 1.
•7. Use of systemic alopecia areata therapies (e.g. prednisone, cyclosporine, methotrexate), including use of these medications for other indications, and intralesional corticosteroids within 1 month prior to Visit 1.
•8. Administration of hydroxychloroquine or finasteride within two months prior to Visit 1.
•9. Use of phototherapy, laser therapy or excimer laser therapy on the scalp within three months prior to Visit 1.
•10. Use of infliximab within two months, adalimumab within three months, and ustekinumab within four months prior to Visit 1 or use of other TNF inhibitors and biologic agents within one month or five half-lives before Visit 1, whichever is longer.
+6 more criteria

Locations (3)

Multicenter Clinical Trials

Sofia, Bulgaria

Centre Sabourand - Hospital Saint-Louis, 1, Avenue Claude Vellefaux

Paris, France

Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Key Dates

Start Date

February 1, 2018

Primary Completion Date

March 14, 2022

Completion Date

September 14, 2022

Last Updated

December 12, 2023

Enrollment

107

ACTUAL participants

Conditions

Alopecia AreataPediatric Disorder

Interventions

LH-8

DRUG

Placebo

DRUG

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

NCT06826196

Alopecia Areata (AA)

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RECRUITING

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

NCT06562270

Alopecia Areata

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RECRUITINGPHASE3

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

Inclusion Criteria

Exclusion Criteria

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata

CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata

A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.