BACKGROUND: The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well-established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD-cream is an easily spreadable cream based on PAD TechnologyTM, an innovative formulation and drug delivery system. OBJECTIVES AND METHODS: A Phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-cream as well as treatment acceptability compared to CAL/BDP gel and PAD-cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8. RESULTS: The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to PAD-cream vehicle (11.7%; p < 0.0001) and non-inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two-step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD-cream (50.7%) compared to PAD-cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD-cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated. CONCLUSION: CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient-reported treatment convenience.
- MeSH
- betamethason škodlivé účinky MeSH
- dermatologické látky * škodlivé účinky MeSH
- emoliencia terapeutické užití MeSH
- fixní kombinace léků MeSH
- kalcitriol škodlivé účinky MeSH
- lidé MeSH
- psoriáza * farmakoterapie chemicky indukované MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- MeSH
- fungicidy průmyslové škodlivé účinky MeSH
- karcinogeny MeSH
- morfoliny škodlivé účinky MeSH
- mutageny MeSH
- myši MeSH
- Check Tag
- myši MeSH
- MeSH
- benomyl toxicita MeSH
- benzimidazoly toxicita MeSH
- dusitany MeSH
- experimentální nádory chemicky indukované MeSH
- fungicidy průmyslové toxicita MeSH
- karbamáty toxicita MeSH
- myši MeSH
- nádory brzlíku chemicky indukované MeSH
- nehodgkinský lymfom chemicky indukované MeSH
- nitrosaminy metabolismus toxicita MeSH
- zvířata MeSH
- Check Tag
- myši MeSH
- zvířata MeSH
