Pacor 2006.

Methods	Parallel‐group, randomised controlled trial This study was carried out in a secondary care setting. It was a single‐centre study conducted in Italy
Participants	28 participants with moderate to severe nickel sulphate‐induced allergic contact dermatitis based on clinical history (hand eczema) and proven by patch testing, resistant to topical corticosteroids No dropouts Inclusion criteria of the trial Moderate to severe nickel sulphate‐induced allergic contact dermatitis based on clinical history (hand eczema) and prior patch testing Resistant to topical corticosteroids Exclusion criteria of the trial Treatment with systemic corticosteroids, cytotoxic agents, or phototherapy within 6 weeks before participation Previous treatment with tacrolimus Pregnancy and lactation Study population Gender: 24 female, 4 male Age: range 17 to 58 years
Interventions	Intervention • 0.1% tacrolimus ointment twice daily for 2 weeks in 14 participants Control intervention • Vehicle twice daily for 2 weeks in 14 participants 2 weeks of treatment was followed by 1 week of follow‐up Duration 3 weeks (2 weeks active treatment, 1 week follow‐up)
Outcomes	Primary outcomes of the trial Not defined Other outcomes Participant's assessment of the following symptoms: erythema, oozing, scaling, itching, on a 4‐point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe on a daily diary card Investigator's Global Assessment reduction in severity: 0 = no improvement, 1 = mild improvement, 2 = marked improvement, 3 = complete remission Adverse events Frequency of rescue medication usage
Notes	Unclear from the abstract whether all participants had hand eczema, but contact with study authors confirmed that all participants had active hand eczema at the beginning of the trial. Treatment started after a run‐in period of 7 days The primary outcome percentage of participants with participant‐rated good/excellent control and the secondary outcome ‐ reduction in severity, investigator‐rated ‐ were included in the study, but no reproducible data were provided Study authors were contacted on 28 February 2014 and replied 2 March 2014 Declarations of interest: none declared Funding: the study was supported by grants from the Ministero Italiano Universita e Ricerca (MIUR) Sample size rationale: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a randomized, double‐blind, placebo‐controlled, parallel‐group study design..." Comment: study authors state this is a randomised study but gave no details in the article Personal communication clarified that StatsDirect Statistical software was used, which is considered to provide adequate random sequence generation
Allocation concealment (selection bias)	Low risk	No details in the article about how allocation was concealed from participants and clinicians. Personal communication revealed that the personnel recruiting participants were unaware of treatment allocation because this was done by a third party (the hospital pharmacist)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "the test compounds were contained in opaque syringes and the treatment was not distinguishable from placebo and was blinded for both investigator and patients" Comment: the authors state that the study uses a double‐blind design. The placebo ointment of tacrolimus was made of the same components as the study drug, only without the active component. All personnel involved in direct contact with participants were unaware of treatment allocation. Only the pharmacist was aware of the allocation
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "the test compounds were contained in opaque syringes and the treatment was not distinguishable from placebo and was blinded for both investigator and patients" Comment: the article claims to be double‐blind. Personal communication with the study author clarified that the outcomes were observed by a blind observer and were analysed in blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the study (28 of 28 = 100%)
Selective reporting (reporting bias)	Low risk	No trial registration found. No major discrepancies between Methods and Results sections
Other bias	Low risk	Baseline comparisons: no significant difference between groups in terms of age, gender, and severity of hand eczema Diagnostic certainty: yes The study was completed