Abstract | BACKGROUND: METHODS: The randomized, parallel-group, investigator-blinded Phase III, 12-week PSO-ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild-to-severe psoriasis were randomized 4:4:1:1 to once-daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout. RESULTS: A total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%). CONCLUSION: Cal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.
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Authors | C Paul, L Stein Gold, F Cambazard, R E Kalb, D Lowson, B Bang, C E M Griffiths |
Journal | Journal of the European Academy of Dermatology and Venereology : JEADV
(J Eur Acad Dermatol Venereol)
Vol. 31
Issue 1
Pg. 119-126
(01 2017)
ISSN: 1468-3083 [Electronic] England |
PMID | 27531752
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2016 European Academy of Dermatology and Venereology. |
Chemical References |
- Aerosols
- Gels
- calcipotriene
- betamethasone-17,21-dipropionate
- Betamethasone
- Calcitriol
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Topics |
- Adult
- Aerosols
- Betamethasone
(administration & dosage, analogs & derivatives)
- Calcitriol
(administration & dosage, analogs & derivatives)
- Female
- Gels
- Humans
- Male
- Middle Aged
- Psoriasis
(drug therapy)
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