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Efficacy and safety of calcipotriol (MC 903) ointment in psoriasis vulgaris

1992; Elsevier BV; Volume: 27; Issue: 6 Linguagem: Inglês

10.1016/0190-9622(92)70299-u

1097-6787

Louis Dubertret, Daniel Wallach, P Souteyrand, Marc Perussel, B Kalis, J Meynadier, J. Chevrant‐Breton, C Beylot, J Bazex, Hans J. Jürgensen,

Dermatology and Skin Diseases

Background: The biologically active form of vitamin D3, calcitriol, may offer a new therapeutic approach to psoriasis, Calcipotriol, a new vitamin D3 analogue, is at least 100 times less calcemic than calcitriol. Objective: Our purpose was to study the efficacy and safety of calcipotriol in the treatment of psoriasis vulgaris. Methods: In a right/left comparative, double-blind study, treatment with calcipotriol ointment (50 μg/gm) twice daily and placebo was given for 4 weeks. The preferred treatment was continued, without opening the code, for another 4 weeks. Efficacy, as measured by the Psoriasis Area and Severity Index and by the investigator's and patient's global assessment, and safety were assessed every 2 weeks. Results: The mean Psoriasis Area and Severity Index fell in 4 weeks from 14.2 to 6.3 with calcipotriol and from 14.1 to 9.2 with placebo (p < 0,001; 95% confidence interval for difference: 1.78→ 3.94). Local side effects were equally common with calcipotriol and placebo. The mean serum calcium remained unchanged. Conclusion: Topical application of up to 50 gm of calcipotriol ointment per week was found to be an effective and safe treatment of psoriasis vulgaris. Background: The biologically active form of vitamin D3, calcitriol, may offer a new therapeutic approach to psoriasis, Calcipotriol, a new vitamin D3 analogue, is at least 100 times less calcemic than calcitriol. Objective: Our purpose was to study the efficacy and safety of calcipotriol in the treatment of psoriasis vulgaris. Methods: In a right/left comparative, double-blind study, treatment with calcipotriol ointment (50 μg/gm) twice daily and placebo was given for 4 weeks. The preferred treatment was continued, without opening the code, for another 4 weeks. Efficacy, as measured by the Psoriasis Area and Severity Index and by the investigator's and patient's global assessment, and safety were assessed every 2 weeks. Results: The mean Psoriasis Area and Severity Index fell in 4 weeks from 14.2 to 6.3 with calcipotriol and from 14.1 to 9.2 with placebo (p < 0,001; 95% confidence interval for difference: 1.78→ 3.94). Local side effects were equally common with calcipotriol and placebo. The mean serum calcium remained unchanged. Conclusion: Topical application of up to 50 gm of calcipotriol ointment per week was found to be an effective and safe treatment of psoriasis vulgaris.