Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: LH-8 Cutaneous Solution herbal derived complex substance: 0.126 ml per spray
Subjects aged 2 to =15 years: 7 sprays twice daily.
Subjects older than 15 years: 8 sprays twice daily.
Co
Sponsors
Legacy Healthcare France
Eligibility
Inclusion criteria
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 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
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 adolescent 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 Photography, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the therapeutic efficacy of a 24-week regimen of administration of LH-8 cutaneous solution twice daily, in children and adolescents (2 to less than 18 years) with chronic moderate-to-severe scalp alopecia areata.Timepoint: Visit 0 to Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess quality of life, acceptability and tolerability through self-evaluation as well as parental evaluationTimepoint: Visit 0 to Visit 5;To assess the efficacy, safety and tolerability of LH-8 cutaneous solution, including the ocular irritant potential and non-irritant potential on skin. Timepoint: Visit 0 to Visit 5;To assess the rate of spontaneous remission in placebo treated patients whose alopecia areata has been active for 6-12 months compared with those whose alopecia areata has been active for greater than 12 months.Timepoint: Visit 0 to Visit 5;To assess the treatment effect on hair follicles in non-alopecic areas.Timepoint: Visit 0 to Visit 5;To evaluate duration of the treatment effect after 6 months of treatment-free period.Timepoint: Visit 0 to Visit 5 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
CliniExperts Research Services Private Limited
Outcome results
None listed