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

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

Study Overview

• Status: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: LEO 124249; Other: Ointment vehicle

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Investigational Site
  • Gentofte, Denmark, 2820
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 124249 ointment 30 mg/g; Ointment to be applied on the eyebrow twice daily.	Drug: LEO 124249; Ointment containing LEO 124249
Placebo Comparator: LEO 124249 ointment vehicle; Ointment to be applied on the eyebrow twice daily.	Other: Ointment vehicle; Ointment without active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.	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	baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Complete response - ≥ 8 Partial response - 4-<8 Minimal response - 1-<4 No response - <1	baseline to Week 12
Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score	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	baseline to Week 12

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): May 16, 2018
• Study Completion (Actual): May 16, 2018

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: EXP-1377; 2017-002720-24 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No