Alopecia Areata
Conditions
Brief summary
This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.
Interventions
DRUGLEO 124249
Ointment containing LEO 124249
OTHEROintment vehicle
Ointment without active ingredients
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator. * Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening. * Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
Exclusion criteria
* Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator. * Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo. * Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation. * Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs). * Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth. | baseline to week 12 | The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following: 1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent AEs (including AEs relating to local tolerability) | baseline to week 12 | — |
| Degree of response in change from baseline to Week 12 for ASoverall L+R | baseline to Week 12 | Complete response - ≥ 8 Partial response - 4-\<8 Minimal response - 1-\<4 No response - \<1 |
| Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score | baseline to Week 12 | Is the appearance of the eyebrows cosmetically normal and acceptable? Yes - 1 No - due to insufficient regrowth area - 2 No - due to insufficient density - 3 No - due to uneven distribution - 4 No - due to other reason (explain, including combination of the above) - 5 |
Countries
Denmark
Outcome results
None listed