LEO 124249 Ointment in the Treatment of Alopecia Areata

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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).