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

NCT03325296 | Terminated Phase 2

• 2 other identifiers: EXP-13772017-002720-24
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score

  baseline to Week 12

Study Arms (2)

LEO 124249 ointment 30 mg/g

EXPERIMENTAL

Ointment to be applied on the eyebrow twice daily.

Drug: LEO 124249

LEO 124249 ointment vehicle

PLACEBO COMPARATOR

Ointment to be applied on the eyebrow twice daily.

Other: Ointment vehicle

Interventions

LEO 124249 DRUG

Ointment containing LEO 124249

LEO 124249 ointment 30 mg/g

Ointment vehicle OTHER

Ointment without active ingredients

LEO 124249 ointment vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Investigational site

Aarhus, 8000, Denmark

Location

Investigational site

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Ointments

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Study Director

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: October 30, 2017
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: February 24, 2025

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)