Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double-blind, exploratory study.
A two-compound ointment containing calcipotriol plus betamethasone dipropionate is an effective treatment for psoriasis vulgaris. The same active ingredients have now been combined in a gel formulation. Our objective was to compare the efficacy and safety of once daily treatment of the two-compound gel with the single components in the same gel vehicle and the gel vehicle alone, in patients with psoriasis vulgaris on the trunk and/or limbs. 364 patients received once daily treatment for up to 8 weeks with either the two-compound gel, the single components in the gel vehicle or the gel vehicle alone. The percentage of patients whose disease was clear or very mild and who had at least a two-step improvement in the Investigator's Global Assessment of disease severity at week 8, was significantly higher with calcipotriol plus betamethasone dipropionate (27.2%) than with betamethasone dipropionate (16.9%, p = 0.027), calcipotriol (11.4%, p = 0.006) or gel vehicle (0.0%, p < 0.001). This exploratory study showed that the two-compound gel was safe and more efficacious than its individual ingredients in the treatment of psoriasis vulgaris.
Fleming
Colin
C
Ninewells Hospital and Medical School, Dundee, United Kingdom, LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark.
Ganslandt
Cecilia
C
Guenther
Lyn
L
Johannesson
Anders
A
Buckley
Colin
C
Simon
Jan C
JC
Stegmann
Helen
H
Vestergaard Tingleff
Lotte
L
D000287:Administration, Topical; D000704:Analysis of Variance; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001623:Betamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005060:Europe; D005260:Female; D005782:Gels; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D008297:Male; D008875:Middle Aged; D009824:Ointments; D014677:Pharmaceutical Vehicles; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D007070:Immunoglobulin A; D009824:Ointments; D014677:Pharmaceutical Vehicles; C055085:calcipotriene; D001623:Betamethasone; D002117:Calcitriol