LEO 124249 Ointment in the Treatment of Alopecia Areata

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LEO 124249

LEO 124249 ointment 30 mg/g twice daily

Group Type EXPERIMENTAL

LEO 124249

Intervention Type DRUG

Vehicle

LEO 124249 ointment vehicle twice daily

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Interventions

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LEO 124249

Intervention Type DRUG

Vehicle

Intervention Type OTHER

Other Intervention Names

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LEO 124249 Ointment LEO 124249 Vehicle

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No