The safety of calcitriol 3 microg/g ointment. Evaluation of cutaneous contact sensitization, cumulative irritancy, photoallergic contact sensitization and phototoxicity.
Vitamin D analogues are widely used for the treatment of psoriasis. A new topical formulation of calcitriol (3 microg/g ointment) has been shown to be effective in the treatment of stable plaque-type psoriasis. This paper reports the results of four separate studies designed to evaluate specific local-safety parameters: cumulative irritancy, cutaneous contact sensitization, potential photoallergic contact sensitization and phototoxicity. Calcitriol 3 microg/g ointment was classified as non-irritant when compared to calcipotriol, tacalcitol and white petrolatum. Petrolatum and tacalcitol were slightly irritant and calcipotriol moderately irritant. No sensitization was observed with calcitriol 3 microg/g ointment. With regard to phototoxic potential, sites treated with calcitriol 3 microg/g ointment or vehicle ointment were less irritated than those treated with white petrolatum or those that were untreated. Using standard photoallergenicity testing methodology, there were no skin reactions of a photoallergic nature to the study material. These studies showed that calcitriol 3 microg/g ointment is a well-tolerated treatment for stable plaque-type psoriasis.
Queille-Roussel
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C
CPCAD, Hôpital L' Archet 2, BP 3079, 06202 Nice Cedex, France.
Duteil
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L
Parneix-Spake
A
A
Arsonnaud
S
S
Rizova
E
E
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D002117:Calcitriol / Q000009:adverse effects* / Q000031:analogs & derivatives; D017449:Dermatitis, Allergic Contact / Q000209:etiology* / Q000473:pathology; D017454:Dermatitis, Photoallergic / Q000209:etiology* / Q000473:pathology; D017484:Dermatitis, Phototoxic / Q000209:etiology* / Q000473:pathology; D003879:Dermatologic Agents / Q000009:adverse effects*; D004100:Dihydroxycholecalciferols / Q000009:adverse effects*; D004643:Emollients / Q000009:adverse effects*; D006801:Humans; D009824:Ointments; D010577:Petrolatum / Q000009:adverse effects*; D011565:Psoriasis / Q000188:drug therapy*; D012449:Safety; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors
D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D004100:Dihydroxycholecalciferols; D004643:Emollients; D009824:Ointments; C055085:calcipotriene; C023850:1 alpha,24-dihydroxyvitamin D3; D010577:Petrolatum; D002117:Calcitriol