Abstract |
Tacrolimus ointment is a topical immunomodulator. Currently, there is available evidence regarding the potential use of topical tacrolimus in a range of dermatological disorders. The aim of this study was to evaluate the efficacy and safety of tacrolimus ointment 0.1% for the nickel sulfate-induced steroid-resistant allergic contact dermatitis (ACD). A randomized, double-blind, placebo-controlled, parallel-group study design was performed in a total of 28 patients affected by nickel sulfate-induced steroid-resistant ACD after a 14-day run-in period. Then, the enrolled patients were randomized into two subgroups. Group A was treated with tacrolimus for 14 days and finally observed for a 7-day follow-up period. Group B, instead, was treated with placebo (vehicle). Four major symptoms ( erythema, oozing, scaling, and itching) were considered as outcomes during the different phases of the study. In group A, during the treatment period with tacrolimus, a significant improvement was observed in all four considered symptoms. On the other hand, no improvement in symptoms was observed in the placebo-treated group B. Local adverse events in the tacrolimus-treated group, such as burning/ itching at the application site, were transient and well tolerated. No patients withdrew because of burning/ itching. In our study, tacrolimus ointment 0.1% appeared to be both effective and safe in the treatment of nickel sulfate-induced steroid-resistant ACD.
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Authors | Maria L Pacor, Gabriele Di Lorenzo, Nicola Martinelli, Pasquale Mansueto, Simonetta Friso, Maria Esposito Pellitteri, Gaetana Di Fede, Giovambattista Rini, Roberto Corrocher |
Journal | Allergy and asthma proceedings
(Allergy Asthma Proc)
2006 Nov-Dec
Vol. 27
Issue 6
Pg. 527-31
ISSN: 1088-5412 [Print] United States |
PMID | 17176790
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenal Cortex Hormones
- Immunosuppressive Agents
- Irritants
- Ointments
- nickel sulfate
- Nickel
- Tacrolimus
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Topics |
- Adolescent
- Adrenal Cortex Hormones
(pharmacology)
- Adult
- Dermatitis, Allergic Contact
(drug therapy)
- Double-Blind Method
- Drug Resistance
- Female
- Humans
- Immunosuppressive Agents
(adverse effects, therapeutic use)
- Irritants
- Male
- Middle Aged
- Nickel
(adverse effects)
- Ointments
- Tacrolimus
(adverse effects, therapeutic use)
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