Safety and efficacy of calcipotriene alone or in fixed combination with betamethasone dipropionate in pediatric patients have not been established.
For the management of plaque psoriasis, calcipotriene 0.005% cream is applied as a thin film and rubbed gently and completely into the affected area twice daily. Safety and efficacy of calcipotriene cream have been demonstrated in patients receiving the drug for 8 weeks.
For the topical treatment of plaque psoriasis, the fixed-combination ointment containing calcipotriene 0.005% and betamethasone 0.05% should be applied and rubbed gently into the affected area(s), until absorbed, once daily. The fixed-combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the fixed-combination ointment should not exceed 100 g of ointment per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the fixed-combination preparation, unless directed by a clinician. The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, and pustular psoriasis or in patients with preexisting skin atrophy at the treatment site.
For chronic, moderately severe psoriasis of the scalp, the hair should be combed to remove scaly debris and, after the hair has been parted to reveal the affected area, the 0.005% solution should be applied only to the affected area and rubbed gently and completely into the scalp twice daily. Care should be taken to avoid contact of the drug with the forehead or uninvolved scalp margins. The solution should not be used in patients with acute psoriatic eruptions of the scalp.
For the topical treatment of moderate to severe plaque psoriasis of the scalp, the fixed-combination suspension containing calcipotriene 0.005% and betamethasone 0.05% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until clearing of psoriatic lesions occurs. The bottle should be shaken prior to each use. The manufacturer states that dosage of the combination suspension should not exceed 100 g of suspension per week, and duration of therapy should not exceed 8 weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician. In addition, the combination suspension should not be used in patients with preexisting skin atrophy at the treatment site.
Most patients with psoriasis received topical calcipotriene 0.005% cream or solution in adequate well-controlled clinical trials of 8 weeks' duration. Results of controlled clinical studies indicate that twice-daily topical application of calcipotriene 0.005% cream or solution usually results in apparent improvement within 2 weeks; after 8 weeks of therapy, continued improvement was observed in 50 or 31% of patients receiving the cream or solution, respectively, while only 4 or 14% of patients showed complete clearing of lesions receiving calcipotriene cream or solution, respectively.
In a multicenter, double-blind, controlled study in patients with mild to very severe plaque psoriasis, absent or very mild disease after 4 weeks of treatment was reported in 48, 16.5, 26.3, and 7.6%, respectively, of patients receiving fixed-combination ointment containing calcipotriene and betamethasone dipropionate, calcipotriene alone, betamethasone dipropionate alone, and vehicle alone. In multicenter, randomized, double-blind studies in patients with moderate to very severe scalp psoriasis, clear or almost clear disease after 8 weeks of once-daily treatment was observed in 67.2-70, 59.6-63.1, and 36.7-41%, of patients receiving fixed-combination suspension containing calcipotriene and betamethasone dipropionate, betamethasone dipropionate monotherapy, and calcipotriene monotherapy, respectively.
Topically applied calcipotriene may be absorbed in sufficient amounts to produce systemic effects; elevated serum calcium concentrations have been observed with use of topical calcipotriene. If elevations in serum calcium concentration occur, use of calcipotriene preparations should be discontinued until normal serum calcium concentrations have been restored. Preparations containing calcipotriene should not be used in patients with demonstrated hypercalcemia or evidence of vitamin D toxicity (hypervitaminosis D) or in patients with known or suspected disorders of calcium metabolism.
Calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors; patients who apply calcipotriene to exposed areas of the body should minimize exposure to sunlight or artificial ultraviolet light (e.g., sunlamps, tanning booths). In addition, the manufacturer states that clinicians may want to limit or avoid use of phototherapy in patients using calcipotriene alone or in fixed combination with betamethasone dipropionate.