Fowler 2005.
Methods | Within‐participant, randomised controlled trial of 3 parallel groups This was a multi‐centre study conducted in the USA and carried out in a secondary care setting |
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Participants | 86 participants with chronic hand eczema
Dropouts: 4 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention
• Hydrocortisone butyrate 0.1% cream on the one hand vs fluticasone propionate 0.05% cream twice daily on the other hand for 2 weeks in 26 participants
• Hydrocortisone butyrate 0.1% cream on the one hand vs prednicarbate emollient 0.1% cream twice daily on the other hand for 2 weeks in 28 participants
• Hydrocortisone butyrate 0.1% cream on the one hand vs mometasone furoate 0.1% cream twice daily on the other hand for 2 weeks in 31 participants Duration 2 weeks |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Three participants with atopic dermatitis participated in the study. Percentage of hand involvement was the only outcome whereby exclusively participants with hand eczema were analysed. Each intervention group had a within‐participant design. in addition, the difference in efficacy between the 3 groups was evaluated The study did include a participant‐ and investigator‐rated severity score, but we were unable to use the data. The study also included adverse events, but we were unable to use this information because only numbers for both treatment groups combined were stated Study authors were contacted on 4 March 2014 and replied 6 March 2014 Declarations of interest: 2 study authors acted as consultants Funding: the study was funded by Ferndale Laboratories, Inc., manufacturer of the study drugs. Two study authors were investigator and consultant for Ferndale Laboratories, Inc. Sample size rationale: not stated; personal communication clarified this was not conducted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomised in balanced cohorts to 3 parallel treatment groups" Comment: no further details given in the article; personal communication with the study author clarified that a computer programme was used to create the randomisation code |
Allocation concealment (selection bias) | Low risk | No details in the article about how allocation was concealed from participants and investigators. Personal communication revealed that allocation was conducted by the sponsor, who was at a remote site. Participants were enrolled without knowledge of the expected treatment group |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the medication[s] were dispensed to the subjects in blind‐labelled tubes that were clearly marked with the subject's identification number and the word left or right" Comment: study authors state double‐blind design. The sponsor and the study co‐ordinator had access to the randomisation code list; treating physicians and participants were unaware of this |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind study, which includes observer blinding. Observers had no access to the randomisation code and were truly blinded (personal communication) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (82 of 86 = more than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found; however all outcomes described in the Methods section are described in the Results |
Other bias | Low risk | Baseline comparisons: no significant differences among the 3 groups in terms of age, gender, race, and eczema severity Diagnostic certainty: yes The study was completed |