Clinical trial NCT03325296: Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.
Official title: Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.
timeFrame: baseline to week 12
Secondary outcomes:
measure: Treatment emergent AEs (including AEs relating to local tolerability)
timeFrame: baseline to week 12
measure: Degree of response in change from baseline to Week 12 for ASoverall L+R
timeFrame: baseline to Week 12
measure: Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score
timeFrame: baseline to Week 12
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Investigational site
city: Gentofte
country: Denmark
facility: Investigational site
Study officials:
affiliation: LEO Pharma
name: Study Director
role: STUDY_DIRECTOR
References: