LEO 124249 Ointment in the Treatment of Alopecia Areata

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Brief Title

LEO 124249 Ointment in the Treatment of Alopecia Areata

Official Title

Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata

Brief Summary

      This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in
      the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
    

Detailed Description

      The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO
      124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of
      hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to
      evaluate hair regrowth, to determine subject quality of life, and to explore disease
      mechanism and its biomarkers.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Severity of Alopecia Areata Tool (SALT) Score

Secondary Outcome

 Summary of Absolute SALT Score

Condition

Alopecia Areata

Intervention

LEO 124249

Study Arms / Comparison Groups

 LEO 124249
Description:  LEO 124249 ointment 30 mg/g 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

40

Start Date

January 2016

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects must have signed and dated informed consent after receiving verbal and
             written information about the clinical trial.

          -  Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia
             areata (patch type, totalis, universalis), as determined by the (sub) investigator,
             affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1,
             baseline).

          -  Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time
             limit.

          -  Subject must accept to not cut hair in the treated scalp areas during the trial.

        Exclusion Criteria:

          -  Females who are pregnant or are breast feeding.

          -  Current signs of spontaneous hair regrowth.

          -  Diffuse type alopecia areata.

          -  Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and
             Ludwig stage II and III)

          -  Subjects with changed or expected changes in medication for thyroid disease within 6
             month before Visit 1 (screening) or during the trial.

          -  Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine,
             azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy
             that in the opinion of the investigator could affect hair regrowth, within 6 weeks
             prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg
             prednisone for asthma or rhinitis may be used).
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Emma Guttman, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02561585

Organization ID

EXP-1222


Responsible Party

Sponsor

Study Sponsor

LEO Pharma


Study Sponsor

Emma Guttman, MD, PhD, Principal Investigator, The Icahn School of Medicine, Mount Sinai Hospital


Verification Date

February 2019