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LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT02132936
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : May 2, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris (Plaque Psoriasis) Drug: LEO 90100 aerosol foam Drug: Aerosol foam vehicle Drug: Calcipotriol BDP gel Drug: Gel vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015


Arm Intervention/treatment
Experimental: LEO 90100
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
Drug: LEO 90100 aerosol foam
Placebo Comparator: Aerosol foam vehicle
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Drug: Aerosol foam vehicle
Active Comparator: Calcipotriol BDP gel
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Drug: Calcipotriol BDP gel
Placebo Comparator: Gel vehicle
Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Drug: Gel vehicle



Primary Outcome Measures :
  1. Treatment Success According to the PGA [ Time Frame: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel ]

    To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.

    Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA).

    'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.



Secondary Outcome Measures :
  1. Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel. [ Time Frame: Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel ]
    Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.

  2. Time to 'Treatment Success' According to PGA. [ Time Frame: From Baseline to Week 12 ]

    Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.

    'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.


  3. Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group). [ Time Frame: Baseline to Week 4 ]
    Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).

  4. Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel). [ Time Frame: Baseline to Week 4; Baseline to Week 8 ]
    Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or above
  • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
  • A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
  • A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Exclusion Criteria:

  • Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

    • etanercept - within 4 weeks prior to randomisation
    • adalimumab, infliximab - within 8 weeks prior to randomisation
    • ustekinumab - within 16 weeks prior to randomisation
    • other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation)
  • Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
  • Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
  • Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
  • Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation
  • Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation
  • Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding

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): NCT02132936


Locations
France
Service de Dermatologie, Hôspital Larrey
Toulouse, France, 31059
Sponsors and Collaborators
LEO Pharma

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Clinical Trials at LEO Pharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02132936     History of Changes
Other Study ID Numbers: LP0053-1003
First Posted: May 7, 2014    Key Record Dates
Results First Posted: May 2, 2016
Last Update Posted: August 15, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents