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

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Brief Title

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.

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Treatment emergent AEs (including AEs relating to local tolerability)

Condition

Alopecia Areata

Intervention

LEO 124249

Study Arms / Comparison Groups

 LEO 124249 ointment 30 mg/g
Description:  Ointment to be applied on the eyebrow twice daily.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

13

Start Date

October 30, 2017

Completion Date

May 16, 2018

Primary Completion Date

May 16, 2018

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Study Director, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03325296

Organization ID

EXP-1377

Secondary IDs

2017-002720-24

Responsible Party

Sponsor

Study Sponsor

LEO Pharma


Study Sponsor

Study Director, Study Director, LEO Pharma


Verification Date

July 2018