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

NCT02132936 | Completed Phase 3 Results

• 1 other identifier: LP0053-1003
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Subjects With PASI 75 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.

  From Baseline to Week 12

• Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).

  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).

  Baseline to Week 4; Baseline to Week 8

Study Arms (4)

LEO 90100

EXPERIMENTAL

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

Aerosol foam vehicle

PLACEBO COMPARATOR

Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks

Drug: Aerosol foam vehicle

Calcipotriol BDP gel

ACTIVE COMPARATOR

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

Gel vehicle

PLACEBO COMPARATOR

Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks

Drug: Gel vehicle

Interventions

LEO 90100 aerosol foam DRUG

LEO 90100

Aerosol foam vehicle DRUG

Aerosol foam vehicle

Calcipotriol BDP gel DRUG

Calcipotriol BDP gel

Gel vehicle DRUG

Gel vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Service de Dermatologie, Hôspital Larrey

Toulouse, 31059, France

Location

Related Publications (4)

• 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.

  PMID: 27531752 RESULT

• 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.

  PMID: 34397196 DERIVED

• 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.

  PMID: 32785881 DERIVED

• 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.

  PMID: 28236223 DERIVED

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

None reported

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

+45 44945888

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 10, 2025
• Results First Posted: May 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)