Clinical study K E Y WORDS psoriasis, calcipotriol cream Calcipotriol cream in childhood psoriasis Calcipotriol cream in childhood psoriasis Short report P. Pauluzzi, A. Doria, C. Nobile and G. Trevisan ABSTRACT Background. Calcipotriol ointment, a vitamin D3 synthetic derivative, confirmed its efficacy and its high safety when employed in the treatment of adult psoriasis and sometimes in children, too. Cream seems to be the most clinically appropriate choice to treat particularly delicate and easily irritable skins. Methods. Nine enrolled psoriatic children (mean age 10.1 ± 4.1 SD years) were treated with calcipotriol cream (50 µg/g) 2 application/day during six consecutive weeks. PASI (Psoriasis Area and Severity lndex) was evaluated at fortnightly visits. Furthermore, routine laboratory parameters were controlled before and at the end of the treatment. Results. Mean PASI was 2.2±0.5 (SEM) at the baseline, and decreased to 0.7±0.5 after six weeks of treatment; a 65.9% reduction was seen. Calcipotriol cream showed an excellent safety, as the lack of irritant cutaneous adverse reactions and/or laboratory parameters alterations. Conclusion. Our clinical experience suggests Calcipotriol cream as one of the most important therapeutic choice in psoriasis. Introduction Child psoriasis involves some difficulties, both in diagnostic and therapeutic approach. A correct diag- nosis, when the disease arises, is obstructecl by both its different clinical expressions ancl the impossibility to carry out a biopsy, in order to obtain the necessary histological findings (1). Consequently, the real pecliatric psoriasis incidence is clifficult to assess. The results of epidemiological studies are contrasting. Up to now, it is ce1tain that pso- riasis arises progressively from infancy to the adult age; 20-25% of psoriatic patients show psoriatic signs also during the earliest years; psoriasis developed before 10 years of age in a 10%, before 5 years in a 5% and before 2 years in a 2-3% of cases (2, 3). The therapeutic approach to the psoriatic chilcl is complicated by both the child compliance, that abso- lutely requires parents/tutor assistance and the derma- tologist's obligation to carefully evaluate the advantage/ acta dermatovenerologica A.P.A. Vol 8, 99, No 3 119 Calcipotriol cream in childhood psoriasis risk ratio linked to therapy, considering both the pati- enr's age and the psoriasis severity ( 4) . Emollients, bath oils, salicylic acid or urea, and non- fluoridated topical steroids for a short-term treatment are preferred treatments. Oral retinoids and PUVA thera- PY are reserved to more severe conditions (5,7) . International experiences show good clinical results, obtained after the administration of calcipotriol oint- ment, a vitamin D3 synthetic derivative, active in the inhib ition of keratinocytes prolife ration, w hile it is characterizecl by a poor activity in increasing calcium metabolism as comparecl w ith 1,25 (OH)2 D3 natura! metabolite (8). Calcipotriol is also available as cream, the most appropriate formulation for particularly delicate types of skin. Substantial clinical experience is at present available on calcipotriol cream in the treatment of adult psoriasis, whereas only few publications on psoriatic children have appeared so far. At present no important side effects are reported (9). The aim of the study was to evaluate efficacy and safe ty of calcipotriol cream (50 pg/ g) in childhood psoriasis . Materials and methods This open study was carried out in accord to the principles of Helsinki Declaration. Nine patients ofboth sexes (5 males, 4 females, mean age 10.1±4.1 SD, range 3-16 years) , w ith psoriatic lesions involving less than 10% of total body surface , were admitted to tbe study. They were affected by psoriasis for 4.4±2.7 years. In 4 out of 9 cases psoriasis was familiar. A w ritten informecl consent, given by co-operative parents was requirecl. Patients were excluclecl if scalp and/ or skin fold psoriasis or hypercalcemia (total serum calcium more than the upper normal limit) were present. Patients who underwent calcium or vitamin D therapy o r other concomitant systemic drugs that could interfere with the clinical results (e.g. systemic steroicls) were also excluclecl from the study. A two-week w ashout p eriod from former anti- psoriatic therapies was planned. During the six weeks of treatment patients were invited to apply calcipotriol cream (50 pg/g) twice a day on psoriatic lesions. At the end of the treatment, patients undetwent a follow-up period of four weeks without therapy. PASI (Psorias is Area ancl Severity Index) w as evaluated at baseline, at two-weekly visits during the trea tment and also at the end of the fo llow-up. Furthermore , routine labo ratory parameters were 120 conrrollecl before and at tbe encl of the six weeks of treatment. Results and conclusions One of the nine patients missed the control visits after two weeks of therapy. In other patients , after six weeks of treatment , erythema , infiltration and scaling were completely clearecl on the trunk, ancl were of milcl severity on the upper ancl lower limbs. A further improvement was observed at the end of follow up . Figure 1 shows the PASI score reduction. Ne ither adve rse skin reactions nor significant alterations of laboratory parameters were noted. Our clinical etata ancl those already publishecl on the same subject (1 0,11), respectively on 66 and 8 children (mean age 9.7 and 8 years; 51% ancl 78.8% PASI reductio n after 8 weeks resp ective ly), show the therapeutic efficacy alreacly evidenc from the seconcl week of treatment. A high topical and systemic tole- rability allows the extension of the treatment period until all the lesions are completely cleared. These etata support the use of calcipotriol cream as the treatment of choice in mile! to moclerate childhoocl psoriasis . Figure 1 . Evaluation of PASI PASI 2.5 / ~ 2 /- 1.5 /~ -43.7% -43.7% ~ ~ v~ - 65.9% ~ 0.5 v- o 1/- baseline 2 4 6 C l i n i c al s t u dy · 54.9% ,L..-- - ~ follow-up acta dermatovenerologica A.P.A. Vol 8, 99, No 3 C linica[ study Calcipotriol cream in childhood psoriasis E FE E C ES l. Gelmetti C, Caputo R. La psoriasi nei bambini in Dubertret L. Psoriasi; Brescia; ISED 1993; Cap. 35: 248. AUTHORS' ADDRESSES 2. Faber EM, Jacobs AH. Infantile psoriasis. AmJ Dis Child; 1977; 131: 1266-9. 3. Nauda A, Kaur S, Kaur I. Childhood psoriasis: an epidemiological survey of 112 patients. Pediatr Dermatol; 1990; 7: 19-21. 4. Menni S. La psoriasi nell'infanzia (from: La Psoriasi, a cura di Aldo Finzi). It Gen Rev Derm; 1994; 31(1-2): 116. 5. Rasmussen JE. Psoriasis in children. Dermatol. Clinics; 1986; 4: 99-106. 6. Bonifazi E., Mazzotta E Traitment du psoriasis de l'enfant. Ann Dermatol Venereol; 1992; 119: 792-5. 7. Herz H, Blum G, Yovalkar S. Holobetasol propionate cream by day and levocabastin ointment at night for the treatment of pediatric patients with chronic, localized plaque psoriasis and atopic dermatitis. J Am Acad Dermatol; 1991; 25: 1166-9. 8. Binderup L, Bramm E. Effect of a novel vitamin D analogne (MC903) on cell proliferation and differentiation in vitro and calcium metabolism in vivo. Biochem. Pharmacol.; 1988; 37(5); 889-95. 9. Ceovic R, Lipozencic J, Pa'ic A. Calcipotriol - a vitanlin D3 analogne (MC903) in the treatment of psoriasis vulgaris: a review. Acta Dermatovenerologica APA 1998; 7: 67-77. 10. Darley CR et al. Safety and efficacy of Calcipotriol ointment (Daivonex) in treating of children with psoriasis vulgaris. Br J Dermatol; 1996; 135: 390-3. 11. Pierini AM, Garcia Dlaz R, Cervini B, Chico A, Tau C. Tolerability and efficacy of topical Calcipotriol in psoriasis. A preliminary report. Ann Dermatol Venereol; 1998; 125: 1321. Paolo Pauluzzi MD, Institute oj Dermatology, University oj Trieste,CattinaraHospital, Strada diFiume, 34149- Trieste, Jtaly AndreaDoriaMD, same address Carla Nobile MD, same address Giusto Trevisan MD, projessor and chairman, same address acta dermatovenerologica A.P.A. Vol 8, 99, No 3 --------------------- -----,------ - - - 121