LEO 124249 Ointment in the Treatment of Alopecia Areata

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LEO 124249

Vehicle

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Northwestern University
The Icahn School of Medicine, Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LEO 124249

Vehicle

Arm Description

LEO 124249 ointment 30 mg/g twice daily

LEO 124249 ointment vehicle twice daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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)

Hair Length

Hair length measured in millimeters.

Hair Growth Rate

Change in hair length measured in millimeters per day.

Relative Hair Thickness

Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.

Hair Type

Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis.

Hair Color

Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.

Global Assessment of Overall Hair Regrowth Compared to Baseline

Based on standardized photographs

Participant's Global Assessment of Hair Regrowth

The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.

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.

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.

Full Information

NCT ID

NCT02561585

First Posted

September 25, 2015

Last Updated

March 19, 2019

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02561585

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LEO 124249

Arm Type

Experimental

Arm Description

LEO 124249 ointment 30 mg/g twice daily

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

LEO 124249 ointment vehicle twice daily

Intervention Type

Drug

Intervention Name(s)

LEO 124249

Other Intervention Name(s)

LEO 124249 Ointment

Intervention Type

Other

Intervention Name(s)

Vehicle

Other Intervention Name(s)

LEO 124249 Vehicle

Primary Outcome Measure Information:

Title

Change in Severity of Alopecia Areata Tool (SALT) Score

Description

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.

Time Frame

From baseline (Day 1) to Week 12 (Day 84)

Secondary Outcome Measure Information:

Title

Summary of Absolute SALT Score

Description

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.

Time Frame

At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)

Title

Summary of Change in SALT Score

Description

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.

Time Frame

From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)

Title

Summary of Relative Change in SALT Score

Description

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.

Time Frame

From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)

Title

Percentage of Patients Who Achieve 50% Improvement in the SALT Score

Description

The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1)

Time Frame

At Week 12 (Day 84)

Title

Hair Length

Description

Hair length measured in millimeters.

Time Frame