Alopecia Areata
Conditions
Interventions
Product Name: Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm
Product Code: LH-8
Pharmaceutical Form: Cutaneous sol
Sponsors
Legacy Healthcare (France) SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 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. Are the trial subjects under 18? yes Number of subjects for this age range: 102 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 adolescents who are pregnant or who are nursing or plan pregnancy during the trial period. 6. Use of topical medication (listed in 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 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. a relative or a 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. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary endpoint: Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. (Visual assessment and global standardised scalp photographs for SALT evaluation.);Timepoint(s) of evaluation of this end point: After 24 weeks of treatment.; Main Objective: Primary: 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. ; Secondary Objective: Secondary: • To assess the efficacy, safety and tolerability of LH-8 cutaneous solution, including the ocular irritant potential and non-irritant potential on skin. • To assess quality of life, acceptability and tolerability through self-evaluation as well as parental evaluation. • To evaluate duration of the treatment effect after 6 months of treatment-free period. • To assess the treatment effect on hair follicles in non-alopecic areas. • 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Either after 24 weeks of treatment or 24 weeks after end of treatment.; Secondary end point(s): Key secondary efficacy endpoints: • Absolute change in SALT score from baseline at the end of 24 weeks’ treatment period. • Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks’ treatment period. Other secondary endpoints: • Adverse events • General physical examination findings, including irritation of eyes and skin • Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.) • Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. • Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation) • Absolute and relative change from baseline in Children’s Dermatology Life Quality Index (CDLQI) scores. • Change in percentage of subjects from baseline by the severity banding CDLQI scores. • Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. • Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline. • Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 5. | — |
Countries
Bulgaria, France, Germany
Contacts
Public ContactHead of Regulatory Affairs
Legacy Healthcare (France) SAS
Outcome results
None listed