- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02561585
LEO 124249 Ointment in the Treatment of Alopecia Areata
Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60208
- Northwestern University
-
-
New York
-
New York, New York, United States, 10029
- The Icahn School of Medicine, Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEO 124249
LEO 124249 ointment 30 mg/g twice daily
|
Other Names:
|
Placebo Comparator: Vehicle
LEO 124249 ointment vehicle twice daily
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Severity of Alopecia Areata Tool (SALT) Score
Time Frame: 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.
|
From baseline (Day 1) to Week 12 (Day 84)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Summary of Absolute SALT Score
Time Frame: 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. |
At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Summary of Change in SALT Score
Time Frame: 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.
|
From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
|
Summary of Relative Change in SALT Score
Time Frame: 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.
|
From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
|
Percentage of Patients Who Achieve 50% Improvement in the SALT Score
Time Frame: 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)
|
At Week 12 (Day 84)
|
Hair Length
Time Frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Hair length measured in millimeters.
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Hair Growth Rate
Time Frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Change in hair length measured in millimeters per day.
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Relative Hair Thickness
Time Frame: 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.
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Hair Type
Time Frame: 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.
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Hair Color
Time Frame: 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.
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Global Assessment of Overall Hair Regrowth Compared to Baseline
Time Frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Based on standardized photographs
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Participant's Global Assessment of Hair Regrowth
Time Frame: 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.
|
At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
|
Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)
Time Frame: 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. |
At baseline (Day 1) and at Week 12 (Day 84)
|
Treatment Satisfaction Questionnaire for Medication Score
Time Frame: 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. |
At Week 12 (Day 84)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emma Guttman, MD, PhD, The Icahn School of Medicine, Mount Sinai Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXP-1222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alopecia Areata
-
Eli Lilly and CompanyRecruitingSkin Diseases | Pathological Conditions, Anatomical | Alopecia | Hypotrichosis | Hair Diseases | Areata AlopeciaUnited States, Taiwan, Japan, Spain, Korea, Republic of, Germany, France, Mexico, Canada, Poland, Australia, Hungary, Argentina
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdActive, not recruitingAlopecia Areata(AA)China
-
University Hospital, RouenCompletedALOPECIA AREATAFrance
-
Services Institute of Medical Sciences, PakistanCompletedExtensive Alopecia AreataPakistan
-
Yale UniversityCompletedAlopecia Areata (AA) | Alopecia Totalis (AT) | Alopecia Universalis (AU)United States
-
Inmagene LLCRecruitingAlopecia Areata (AA)United States, Canada
-
Siriraj HospitalCompletedRecalcitrant Alopecia Totalis | Recalcitrant Alopecia UniversalisThailand
-
University of FloridaWithdrawnFemale Androgenetic AlopeciaUnited States
-
EquilliumWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Lindsey BordoneWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
Clinical Trials on Vehicle
-
Haus BioceuticalsCompletedEczema | Atopic DermatitisIndia
-
PfizerCompleted
-
Bausch Health Americas, Inc.Dow Pharmaceutical SciencesCompleted
-
Bausch Health Americas, Inc.Dow Pharmaceutical SciencesCompleted
-
Instituto Universitario de Oftalmobiología Aplicada...Completed
-
Johns Hopkins Bloomberg School of Public HealthCompletedObesity | Childhood Obesity | Dietary Habits | Water; Lack of | Feeding Behavior | Mother-Child RelationsUnited States
-
Dr. Reddy's Laboratories LimitedSyneos Health; AccelovanceCompletedHead Lice InfestationUnited States
-
University of British ColumbiaUnknownCicatrix | Scar | Keloid | Hypertrophic Scar | Skin Graft Scar | Skin Graft Complications | Donor Site ComplicationCanada
-
Patagonia Pharmaceuticals, LLCCompletedCongenital IchthyosisUnited States
-
AOBiome LLCVeristat, Inc.CompletedPrehypertension | Hypertension, Stage IUnited States