Clinical trial NCT02561585: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Severity of Alopecia Areata Tool (SALT) Score
timeFrame: From baseline (Day 1) to Week 12 (Day 84)
Secondary outcomes:
measure: Summary of Absolute SALT Score
timeFrame: At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Summary of Change in SALT Score
timeFrame: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
measure: Summary of Relative Change in SALT Score
timeFrame: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
measure: Percentage of Patients Who Achieve 50% Improvement in the SALT Score
timeFrame: At Week 12 (Day 84)
measure: Hair Length
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Hair Growth Rate
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Relative Hair Thickness
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Hair Type
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Hair Color
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Global Assessment of Overall Hair Regrowth Compared to Baseline
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Participant's Global Assessment of Hair Regrowth
timeFrame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
measure: Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)
timeFrame: At baseline (Day 1) and at Week 12 (Day 84)
measure: Treatment Satisfaction Questionnaire for Medication Score
timeFrame: At Week 12 (Day 84)
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: The Icahn School of Medicine, Mount Sinai Hospital
state: New York
Study officials:
affiliation: The Icahn School of Medicine, Mount Sinai Hospital
name: Emma Guttman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: