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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

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
Participants 86 participants with chronic hand eczema
 Dropouts: 4
Inclusion criteria of the trial
  • Between 18 and 65 years old

  • Symmetrical hand or atopic dermatitis of moderate severity for at least 2 weeks


Exclusion criteria of the trial
  • Use of systemic treatments in the last month or topical corticosteroids in the last week before study entry


Study population
  • Gender: 52 female, 34 male

  • Age: mean 46 years

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
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Investigator‐rated severity of hand eczema on a 4‐point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) for 4 clinical signs (erythema, cracking/ fissuring, scaling, papules/vesicles)

  • Investigator‐rated severity total sum score

  • Participant‐rated severity of hand eczema on a 4‐point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) for 6 clinical signs (erythema, cracking/ fissuring, scaling, papules/vesicles, pruritus, burning/pain)

  • Participant‐rated severity total sum score

  • Investigator‐rated mean reduction in percentage of hand involvement

  • Participants‐rated preference and cosmetic acceptability

  • Adverse events

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
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