Status:
COMPLETED
Efficacy and Safety of LH-8 in Paediatric Alopecia Areata
Lead Sponsor:
Legacy Healthcare SA
Conditions:
Alopecia Areata
Pediatric Disorder
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
PHASE3
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. P...
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 are...
Eligibility Criteria
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.
- 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.
- Inclusion criteria:
- Male and female children and adolescents aged 2 to less than 18 years.
- Active scalp alopecia areata, involving 25% to 95% of the scalp (as measured by SALT score at screening).
- Duration of hair loss between 6 months and 3 years.
- 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.
- All subjects taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
- Subjects must be willing to maintain the same hair style, including hair dye, throughout the study period.
- 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:
- Hypersensitivity or intolerance to any active IMP substances (onion, citrus, caffeine, theobromine) or excipients (glycerine, betaine or ethanol).
- Any cause of hair loss other than alopecia areata.
- Active scalp inflammation except alopecia areata.
- Nevi, cutaneous or non-cutaneous lesions currently undiagnosed but suspicious for malignancy.
- Female adolescents who are pregnant or who are nursing or plan pregnancy during the trial period.
- Use of topical medication (listed in protocol Section 10.7.1) within 2 weeks prior to Visit 1.
- 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.
- Administration of hydroxychloroquine or finasteride within two months prior to Visit 1.
- Use of phototherapy, laser therapy or excimer laser therapy on the scalp within three months prior to Visit 1.
- 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.
- Prior treatment with IMP.
- Evidence or history of alcohol, medication or drug abuse.
- History of systemic or cutaneous medical, or psychiatric disease which will put subject at risk or interfere with assessments.
- Participation in any other clinical trial within 30 days prior to Visit 1.
- Subject is in a dependent relationship (e.g. relative or family member) with the investigator's or sponsor's staff.
- Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.
Exclusion
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03240627
Start Date
February 1 2018
End Date
September 14 2022
Last Update
December 12 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Multicenter Clinical Trials
Sofia, Bulgaria
2
Centre Sabourand - Hospital Saint-Louis, 1, Avenue Claude Vellefaux
Paris, France, 75010
3
Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117