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

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: LEO 90100 aerosol foam; Drug: Aerosol foam vehicle; Drug: Calcipotriol BDP gel; Drug: Gel vehicle

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Service de Dermatologie, Hôspital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Success According to the PGA	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.	4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With PASI 75 at Week 4 for LEO 90100 and at 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.	Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel
Time to 'Treatment Success' According to PGA.	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.	From Baseline to Week 12
Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).	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).	Baseline to Week 4
Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).	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).	Baseline to Week 4; Baseline to Week 8

Collaborators and Investigators

• Sponsor: LEO Pharma

Publications and helpful links

General Publications

• Veverka KA, Hansen JB, Yaloumis M, Kircik L, Stein Gold L. Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials. J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743.
• Iversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12.
• Paul C, Leonardi C, Menter A, Reich K, Gold LS, Warren RB, Moller A, Lebwohl M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study. Am J Clin Dermatol. 2017 Jun;18(3):405-411. doi: 10.1007/s40257-017-0258-0. Erratum In: Am J Clin Dermatol. 2017 May 24;:
• Paul C, Stein Gold L, Cambazard F, Kalb RE, Lowson D, Bang B, Griffiths CE. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):119-126. doi: 10.1111/jdv.13859. Epub 2016 Aug 17.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: LP0053-1003