Phase 3
Completed N=463
LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT02132936 ↗Enrolled (actual)
463
Serious AEs
1.7%
Results posted
May 2016
Primary outcomePrimary: Treatment Success According to the PGA — 38.3; 22.5 percentage of subjects — p=<0.001
◆ Published Evidence
Highly cited
112citations · ~12 / year
Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.
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
Linked Publications (4)
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Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.
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Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study.
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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.
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Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success According to the PGA |
38.3; 22.5 | <0.001 sig |
| SECONDARY Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel. |
52.1; 34.6 | =0.001 sig |
| SECONDARY Time to 'Treatment Success' According to PGA. |
6; NA | <0.001 sig |
| SECONDARY Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group). |
-30.5; -15.9 | <0.001 sig |
| SECONDARY Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel). |
-30.5; -28.5 | =0.33 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02132936) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.