A double-blind randomized placebo-controlled pilot study comparing topical immunomodulating agents and corticosteroids for treatment of experimentally induced nickel contact dermatitis.
BACKGROUND
Although topical glucocorticoids are effective for most inflammatory skin disorders, their use is limited by local and systemic side effects. Tacrolimus and pimecrolimus are immunomodulators that provide clinicians with steroid-sparing options in the long-term topical treatment of allergic contact dermatitis.


OBJECTIVE
To obtain pilot data regarding the relative efficacies of pimecrolimus 1% cream, tacrolimus 0.1% ointment, clobetasol propionate 0.05% ointment, and triamcinolone acetonide 0.1% ointment, as compared to control preparations (Vanicream and petrolatum), for treatment of experimentally induced nickel contact dermatitis.


METHODS
Twenty-one volunteers with positive patch test reactions to nickel sulfate 5% at six sites (three on each arm) applied each study medication to one nickel site, respectively, twice daily for 14 days. Study medications were prepared in identical syringes, and the site of application was randomly assigned by a computer-generated randomization schedule. Assessments were performed at 3, 7, 10, and 14 days after randomization.


RESULTS
Most reactions were coded as resolved or as almost resolved by day 14 regardless of treatment. Although most pairwise comparisons were not statistically significant, a clear trend was observed for sites treated with active drug to do better than control sites.


CONCLUSIONS
Possible explanations for these results include contamination by neighboring medication sites, timing of assessments, and lack of repeated nickel applications.
Bhardwaj
Sachin S
SS
University of Minnesota, Minneapolis, USA.
Jaimes
Juan P
JP
Liu
An
A
Warshaw
Erin M
EM
D000279:Administration, Cutaneous; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D000485:Allergens / Q000009:adverse effects*; D002990:Clobetasol / Q000008:administration & dosage; D017449:Dermatitis, Allergic Contact / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D008297:Male; D009532:Nickel / Q000009:adverse effects*; D010577:Petrolatum / Q000008:administration & dosage; D010865:Pilot Projects; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D014221:Triamcinolone / Q000008:administration & dosage
D000305:Adrenal Cortex Hormones; D000485:Allergens; D007155:Immunologic Factors; D014221:Triamcinolone; C117268:pimecrolimus; D009532:Nickel; D010577:Petrolatum; D002990:Clobetasol; D016559:Tacrolimus