LEO 124249 Ointment in the Treatment of Alopecia Areata

Phase 2

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: LEO 124249; Other: Vehicle

• Registration Number: NCT02561585
• Lead Sponsor: LEO Pharma

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 Timeline

• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-28
• Study Start: 2016-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Disposition First Submitted: 2017-11-30
• Disposition First Submitted QC: 2017-11-30
• Disposition First Posted: 2017-12-02
• Results First Submitted: 2018-11-23
• Status Verified: 2019-02
• Results First Submitted QC: 2019-03-19
• Results First Posted: 2019-04-16
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 124249	LEO 124249	LEO 124249 ointment 30 mg/g twice daily
Vehicle	Vehicle	LEO 124249 ointment vehicle twice daily

Primary Outcome Measures

Name	Time	Method
Change in Severity of Alopecia Areata Tool (SALT) Score	From baseline (Day 1) to Week 12 (Day 84)	The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.

Secondary Outcome Measures

Name	Time	Method
Summary of Absolute SALT Score	At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss.; Summary of observed values of the absolute SALT score.
Summary of Change in SALT Score	From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)	The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
Hair Color	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.
Global Assessment of Overall Hair Regrowth Compared to Baseline	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	Based on standardized photographs
Participant's Global Assessment of Hair Regrowth	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.
Summary of Relative Change in SALT Score	From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)	The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
Percentage of Patients Who Achieve 50% Improvement in the SALT Score	At Week 12 (Day 84)	The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1)
Hair Length	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	Hair length measured in millimeters.
Hair Growth Rate	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	Change in hair length measured in millimeters per day.
Relative Hair Thickness	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.
Hair Type	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)	Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis.
Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)	At baseline (Day 1) and at Week 12 (Day 84)	The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected).; The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84.; Low score indicating that the participant was least affected by AA.
Treatment Satisfaction Questionnaire for Medication Score	At Week 12 (Day 84)	The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions.; The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment.

Trial Locations

Locations (2)

The Icahn School of Medicine, Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States