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LEO 124249 Ointment in the Treatment of Alopecia Areata

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ClinicalTrials.gov Identifier: NCT02561585
Recruitment Status : Completed
First Posted : September 28, 2015
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE September 25, 2015
First Posted Date  ICMJE September 28, 2015
Results First Submitted Date  ICMJE November 23, 2018
Results First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Change in SALT Score [ Time Frame: From Day 1 to Week 12 ]
Change in SALT score from Baseline to End of Treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • 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.
  • 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.
  • 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.
  • 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)
  • Hair Length [ Time Frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) ]
    Hair length measured in millimeters.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
  • Safety Profile [ Time Frame: From Day 1 to Week 12 ]
    Safety profile by reported AEs
  • Absolute SALT Score [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • SALT Score Change from Baseline [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • SALT Score Percentage Change from Baseline [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • Reduction in SALT Score [ Time Frame: At Day 1 and at Week 12 ]
    The event of having as least 50% reduction in SALT score at Week 12 as compared Day 1
  • Hair Length [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • Hair Growth Rate [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • Relative Hair Thickness [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • Hair Type [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
    Velus hair, terminal hair
  • Hair Color [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • Global Assessment of Hair Regrowth [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
    Based on standardized photographs
  • Subject Global Assessment of Hair Regrowth [ Time Frame: Day 1, Week 4, Week 8, and Week 12 ]
  • Endpoints Derived from the Alopecia Areata Quality of Life Questionnaire [ Time Frame: At Day 1 and at Week 12 ]
    As specified in the statistical analysis plan.
  • Endpoints Derived from the Treatment Satisfaction Questionnaire for Medication [ Time Frame: At Day 1 and at Week 12 ]
    As specified in the statistical analysis plan.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LEO 124249 Ointment in the Treatment of Alopecia Areata
Official Title  ICMJE Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: LEO 124249
    Other Name: LEO 124249 Ointment
  • Other: Vehicle
    Other Name: LEO 124249 Vehicle
Study Arms  ICMJE
  • Experimental: LEO 124249
    LEO 124249 ointment 30 mg/g twice daily
    Intervention: Drug: LEO 124249
  • Placebo Comparator: Vehicle
    LEO 124249 ointment vehicle twice daily
    Intervention: Other: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2015)
35
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02561585
Other Study ID Numbers  ICMJE EXP-1222
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party LEO Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE LEO Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emma Guttman, MD, PhD The Icahn School of Medicine, Mount Sinai Hospital
PRS Account LEO Pharma
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP