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OpenTrials
Completed

NCT Number: NCT02132936

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

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

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de Dermatologie, Hôspital Larrey

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO 90100 aerosol foam

Drug

Aerosol foam vehicle

Drug

Calcipotriol BDP gel

Drug

Gel Vehicle

Drug

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 7, 2014
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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