Efficacy and Safety of LH-8 in Paediatric Alopecia Areata

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.
• •11. Prior treatment with IMP.
• •12. Evidence or history of alcohol, medication or drug abuse.
• •13. History of systemic or cutaneous medical, or psychiatric disease which will put subject at risk or interfere with assessments.
• •14. Participation in any other clinical trial within 30 days prior to Visit 1.
• •15. Subject is in a dependent relationship (e.g. relative or family member) with the investigator's or sponsor's staff.
• •16. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.