Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

Male and female children and adolescents aged 2 to less than 18 years with active alopeciaareata 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 2to 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:

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 SALTscore at screening).
3. Duration of hair loss between 6 months and 3 years.
4. Female subjects of childbearing potential (postmenarcheal) must have a negative urinepregnancy test at screening. Females of childbearing potential must either not besexually active or be using an adequate birth control method throughout the durationof the study.
5. All subjects taking thyroid medication or hormonal therapy must be on a stable dosefor 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 andassent or consent signed by the subjects, if applicable, according to nationalregulations 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 formalignancy.
5. Female adolescents who are pregnant or who are nursing or plan pregnancy during thetrial period.
6. Use of topical medication (listed in protocol Section 10.7.1) within 2 weeks prior toVisit 1.
7. Use of systemic alopecia areata therapies (e.g. prednisone, cyclosporine,methotrexate), including use of these medications for other indications, andintralesional corticosteroids within 1 month prior to Visit 1.
8. Administration of hydroxychloroquine or finasteride within two months prior to Visit
10. Use of phototherapy, laser therapy or excimer laser therapy on the scalp within threemonths prior to Visit 1.
11. Use of infliximab within two months, adalimumab within three months, and ustekinumabwithin four months prior to Visit 1 or use of other TNF inhibitors and biologic agentswithin one month or five half-lives before Visit 1, whichever is longer.
12. Prior treatment with IMP.
13. Evidence or history of alcohol, medication or drug abuse.
14. History of systemic or cutaneous medical, or psychiatric disease which will putsubject at risk or interfere with assessments.
15. Participation in any other clinical trial within 30 days prior to Visit 1.
16. Subject is in a dependent relationship (e.g. relative or family member) with theinvestigator's or sponsor's staff.
17. Any other condition or circumstance that, in the opinion of the investigator, couldcompromise the subject's ability to comply with the study protocol.