Topical tacrolimus 0.1% ointment (protopic) reverses nickel contact dermatitis elicited by allergen challenge to a similar degree to mometasone furoate 0.1% with greater suppression of late erythema.
The aim of this study was to evaluate the ability of topical tacrolimus 0.1% under occlusion for 48 h to suppress nickel-elicited allergic contact dermatitis in a randomized, petrolatum- and mometasone furoate 0.1% ointment-controlled double-blind, intra-individual study which included 28 women volunteers. 3 closed patch tests (Finn Chambers on Scanpor, Epitest Ltd Oy, Tuusula, Finland) containing 0.1 ml of 5% nickel sulfate in petrolatum were applied on day 0. After removal on day 2, the study compounds were applied under occlusion for 48 h. The eczema reaction and the degree of erythema were evaluated clinically and by reflectance spectrophotometry at days 4 and 7, respectively. Mean visual scores corresponding to petrolatum-treated sites were significantly higher than those corresponding to both mometasone furoate and tacrolimus at days 4 (P < 0.001) and 7 (P < 0.001). In both tacrolimus- and mometasone furoate-treated sites, there was a significant decrease in visual scores with time (P < 0.001) from day 2 to day 7, and the corresponding mean decreases in scores were 0.73 and 1.04, respectively. The difference between both was 0.30 in favour of tacrolimus (95% confidence intervals, -0.04 and 0.65), although this did not reach statistical significance (P = 0.084). Mean erythema index values were similar at day 2. Significant differences among treatment sites were seen at days 4 (P < 0.001) and 7 (P < 0.001). The decrease was significantly more pronounced on day 7 in patches where tacrolimus had been supplied (P < 0.5). This method might provide useful means to compare different concentrations and/or presentations of tacrolimus or other calcineurin inhibitors and topical anti-inflammatory agents.
Department of Dermatology, Hospital Santa Creu i Sant Pau, Sant Antoni Maria Claret 167, 08025 Barcelona, Spain. aalomar@hsp.santpau.es
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A
Alomar
L
L
Puig
C M
CM
Gallardo
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N
Valenzuela
D000287:Administration, Topical; D000328:Adult; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D017449:Dermatitis, Allergic Contact / Q000188:drug therapy / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004643:Emollients / Q000627:therapeutic use; D004890:Erythema / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007509:Irritants / Q000009:adverse effects*; D008875:Middle Aged; D000068656:Mometasone Furoate; D009532:Nickel / Q000009:adverse effects*; D009824:Ointments; D010328:Patch Tests; D010577:Petrolatum / Q000627:therapeutic use; D011244:Pregnadienediols / Q000627:therapeutic use; D013053:Spectrophotometry; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors
D018926:Anti-Allergic Agents; D004643:Emollients; D007166:Immunosuppressive Agents; D007509:Irritants; D009824:Ointments; D011244:Pregnadienediols; D000068656:Mometasone Furoate; C029938:nickel sulfate; D009532:Nickel; D010577:Petrolatum; D016559:Tacrolimus