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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 : Completed
First Posted : January 16, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
Comparison of the efficacy of LEO 90100 foam with Dovobet® ointment in the treatment of psoriasis in Japanese subjects.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 90100 foam Drug: Dovobet® ointment Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LEO 90100 Foam in Japanese Subjects With Psoriasis Vulgaris
Actual Study Start Date : January 24, 2019
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: LEO 90100 foam
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
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

Active Comparator: Dovobet® ointment
calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g
Drug: Dovobet® ointment
Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Number adverse events [ Time Frame: From Day 1 to end of Week 4 ]
    Number of treatment emergent adverse events (TEAEs) per subject



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806790


Locations
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Japan
Leo Pharma Investigational Site
Fukutsu, Fukuoka, Japan, 811-3217
Leo Pharma Investigational Site
Obihiro, Hokkaido, Japan, 080-0013
Leo Pharma Investigational Site
Sapporo, Hokkaido, Japan, 004-0063
Leo Pharma Investigational Site
Sapporo, Hokkaido, Japan, 006-0814
Leo Pharma Investigational Site
Sapporo, Hokkaido, Japan, 060-0807
Leo Pharma Investigational Site
Nonoichi, Ishikawa, Japan, 921-8801
Leo Pharma Investigational Site
Kawasaki, Kanagawa, Japan, 213-0001
Leo Pharma Investigational Site
Yokohama, Kanagawa, Japan, 220-6208
Leo Pharma Investigational Site
Sendai, Miyagi, Japan, 981-3133
Leo Pharma Investigational Site
Saitama-shi, Saitama, Japan, 330-0854
Leo Pharma Investigational Site
Itabashi-ku, Tokyo, Japan, 173-8605
Leo Pharma Investigational Site
Kita-ku, Tokyo, Japan, 115-0045
Leo Pharma Investigational Site
Koto-Ku, Tokyo, Japan, 136-0074
Leo Pharma Investigational Site
Minato-Ku, Tokyo, Japan, 108-0014
Leo Pharma Investigational Site
Setagaya, Tokyo, Japan, 158-0094
Leo Pharma Investigational Site
Setagaya, Tokyo, Japan, 158-0097
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03806790     History of Changes
Other Study ID Numbers: LP0053-1422
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases