Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

LEO Pharma

Status and phase: Terminated; Phase 2

Conditions: Alopecia Areata

Treatments: Other: Ointment vehicle; Drug: LEO 124249

Study type: Interventional

Funder types: Industry

Identifiers

NCT03325296

EXP-1377

2017-002720-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

13 participants in 2 patient groups, including a placebo group

LEO 124249 ointment 30 mg/g

Experimental group

Description:

Ointment to be applied on the eyebrow twice daily.

Treatment:

Drug: LEO 124249

LEO 124249 ointment vehicle

Placebo Comparator group

Description:

Ointment to be applied on the eyebrow twice daily.

Treatment:

Other: Ointment vehicle