LEO 124249 Ointment in the Treatment of Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561585
• Other study ID #: EXP-1222
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• LEO 124249

Other:
• Vehicle

Locations

Country	Name	City	State
United States	Northwestern University	Evanston	Illinois
United States	The Icahn School of Medicine, Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Severity of Alopecia Areata Tool (SALT) Score	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.	From baseline (Day 1) to Week 12 (Day 84)
Secondary	Summary of Absolute SALT Score	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.	At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Summary of Change in SALT Score	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.	From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Secondary	Summary of Relative Change in SALT Score	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.	From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Secondary	Percentage of Patients Who Achieve 50% Improvement in the SALT Score	The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1)	At Week 12 (Day 84)
Secondary	Hair Length	Hair length measured in millimeters.	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Hair Growth Rate	Change in hair length measured in millimeters per day.	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Relative Hair Thickness	Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Hair Type	Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis.	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Hair Color	Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Global Assessment of Overall Hair Regrowth Compared to Baseline	Based on standardized photographs	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Participant's Global Assessment of Hair Regrowth	The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.	At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Secondary	Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)	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.	At baseline (Day 1) and at Week 12 (Day 84)
Secondary	Treatment Satisfaction Questionnaire for Medication Score	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.	At Week 12 (Day 84)

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