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Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT03806790
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE January 24, 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Overall improvement rate for the target lesion at Week 4 [ Time Frame: End of Week 4 ]
Overall improvement rate for the target lesion defined as 'substantial resolution' of clinical signs or at least 'moderately improved' in the general change in the target lesion. 'Substantial resolution' is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion. The severity scale for the clinical signs ranges from 0 (no clinical sign) to 4 (severe clinical signs); there are 3 clinical signs in total (redness, thickness, and scaliness).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03806790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • Overall improvement rate for the target lesion at Weeks 1 and 2 [ Time Frame: End of Weeks 1 and 2 ]
    Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.
  • Change in the total sign score from Week 1 to Week 4; [ Time Frame: End of Week 4 ]
    The change in the total sign score from Week 1 to Week 4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion. The severity for each of the 3 clinical signs will be recorded according to a 9-point scale that ranges from a score of 0 to 4 in increments of 0.5; the severities are scored from low to high with 0 = none and 4 = severe.
  • The change in the sum of the total sign scores [ Time Frame: End of Week 4 ]
    The change in the sum of the scores (total sign score) for the severity of the three clinical signs (thickness, scaliness, redness) from Week 1 to the sum of the scores at end of Week 4 for the target lesion.
  • Number adverse events [ Time Frame: From Day 1 to end of Week 4 ]
    Number of treatment emergent adverse events (TEAEs) per subject
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Overall improvement rate for the target lesion at Weeks 1 and 2 [ Time Frame: End of Weeks 1 and 2 ]
    Substantial resolution of clinical signs or at least 'moderately improved' in the general change in the target lesion.
  • Change in the total sign score from Week 1 to Week 4; [ Time Frame: End of Week 4 ]
    The change in the total sign score from Week1 to Week4; total sign score is defined as the sum of the scores from the 3 clinical signs (redness, thickness, and scaliness) assessing severity in the target lesion.
  • The change in the sum of the scores (total sign score) [ Time Frame: End of Week 4 ]
    The change in the sum of the scores (total sign score) for the severity of the three clinical signs (thickness, scaliness, redness) from Week 1 to the sum of the scores at end of Week 4 for the target lesion.
  • Number adverse events [ Time Frame: From Day 1 to end of Week 4 ]
    Number of treatment emergent adverse events (TEAEs) per subject
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Official Title  ICMJE Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Brief Summary Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.
Detailed Description A phase 3, national, multi-centre, 4-week, prospective, randomised, controlled, parallel-group, open trial of LEO 90100 foam versus Dovobet® ointment (both treatments containing calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: LEO 90100 foam
    Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.
    Other Name: Enstilar® Foam
  • Drug: Dovobet® ointment
    Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
Study Arms  ICMJE
  • Experimental: LEO 90100 foam
    calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
    Intervention: Drug: LEO 90100 foam
  • Active Comparator: Dovobet® ointment
    calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
    Intervention: Drug: Dovobet® ointment
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Signed and dated informed consent obtained
  2. Japanese subjects
  3. Aged 20 years or above
  4. Clinical diagnosis of psoriasis vulgaris amenable to topical treatment of less than or equal to 30% BSA (excluding psoriasis on the face/genitals/skin folds).
  5. A target psoriasis lesion of at least mild severity on the body of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of the clinical signs). The lesion must not be on the scalp, face, genitals or skin folds.
  6. Women of childbearing potential must have a negative pregnancy test at Day 1 and agree to use an adequate methods of birth control during the trial.
  7. Able to communicate with the (sub)investigator and understand and comply with the requirements of the trial.

Key Exclusion Criteria:

  1. Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the specified time periods prior to randomisation (depending on treatment)
  2. Systemic treatments with all therapies other than biological treatments with a potential effect on psoriasis vulgaris within 4 weeks prior to randomisation
  3. PUVA therapy, UVB therapy or UVA therapy on the full body or on the target lesion within 4 weeks prior to randomisation
  4. Topical treatment of psoriasis on the areas to be treated with trial medication within 2 weeks prior to randomisation
  5. Topical treatment of psoriasis on the face, genitals or skin folds with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
  6. Topical treatment of conditions other than psoriasis with vitamin D3 analogues, potent corticosteroids or immunosuppressants within 2 weeks prior to randomisation
  7. Initiation or changes of medication that may affect psoriasis vulgaris during the trial
  8. Patients with certain disorders or symptoms present on the areas to be treated with trial medication: viral lesions of the skin, infections, skin manifestations, or fragility of skin veins
  9. Other inflammatory skin diseases that may confound the evaluation of psoriasis vulgaris
  10. Erythrodermic, exfoliative or pustular psoriasis on the areas to be treated with trial medication
  11. Planned excessive exposure of areas to be treated with trial medication to either natural or artificial sunlight during the trial.
  12. Disorders of calcium metabolism
  13. Severe renal insufficiency, severe hepatic disorders or severe heart disease
  14. Hypersensitivity to any components of the investigational medicinal products.
  15. Cushing's disease or Addison's disease
  16. Subjects who have received treatment with any non-marketed drug substance within the 4 weeks prior to randomisation, or longer if for certain biological treatments
  17. History of cancer within the last 5 years (except completely cured skin cancer)
  18. Current participation in any other interventional clinical trial
  19. Previously randomised in this trial
  20. Women who are pregnant, wishing to become pregnant or are breast-feeding
  21. Chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance
  22. Employees of the trial site or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03806790
Other Study ID Numbers  ICMJE LP0053-1422
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data feasibility requests and research proposals are sent to disclosure@leo-pharma.com. If feasibility to share the data from a trial is granted, the ultimate decision is made by an external to the company board (Patient and Scientific Review Board). Data sharing is further subject to signed data sharing agreement. Data will be available in a closed environment for a specified period on time.
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx
URL: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Expert LEO Pharma
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