Kucharekova 2003.

Methods	Parallel‐group, randomised controlled trial This study was carried out in a secondary care setting; it was a single‐centre study. This study was conducted in the Netherlands
Participants	32 participants with bilateral chronic hand dermatitis for more than 6 months, with mild to moderate severity and good response to topical steroids Dropouts: 6 Inclusion criteria of the trial Mild to moderate bilateral hand dermatitis since > 6 months Good response to class I or II topical corticosteroids Exclusion criteria of the trial Clinically relevant allergic or irritant contact dermatitis with inability to avoid exposure Severe and very severe hand eczema Severe vesiculation or bullae History of contact urticaria and pustular disease Recent therapy with class III or IV topical corticosteroids Recent systemic therapy or phototherapy Study population Gender: 22 female, 10 male Age: mean 39.15 years, range 19 to 65 years
Interventions	Intervention • Emollient with ceramides twice daily for 2 months in 14/17 participants • Traditional pet‐based emollient in 12/15 participants Both groups were allowed to use triamcinolone ointment in case of active dermatitis Duration 2 months
Outcomes	Primary outcomes of the trial Not defined Other outcomes Participant‐rated efficacy of response (1 = worse, 2 = no change, 3 = minimal improvement, 4 = moderate improvement, 5 = marked improvement, 6 = clearing or almost clearing) Participant‐rated cosmetic acceptability (very poor, poor, acceptable, good, excellent) Participant‐rated use of corticosteroids and emollients Participant‐rated severity of itch Observer‐rated global assessment of severity with the Investigator Global Assessment (IGA) (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe) at baseline, after 1 and 2 months Observer‐rated Hand Eczema Area and Severity (HEAS) score, which divides the hands into 7 areas; involvement was assessed for each area on a scale of 0 to 4. In each area, intensity of erythema, vesicles, papules, scaling, fissures, excoriations, and hyperkeratosis was scored on a of 0 to 3 scale (0 = none, 1 = slight, 2 = moderate, 3 = severe). The affected area was multiplied by a correction factor and by the sum of intensities of symptoms. Finally, all areas were added up, resulting in a total symptom score Adverse events
Notes	Unclear about 2 dropouts. Study authors state that this is a pilot study. Analysis may have been intention‐to‐treat, but procedure unclear. Results presented graphically, without exact numbers. Accuracy of the statistics is unclear because all between‐group comparisons were conducted at each time individually rather than comparing difference scores between groups. The primary outcomes percentage of participants with self‐rated and observer‐rated improvement and the secondary outcomes reduction in severity, investigator‐rated and participant‐rated, were included in the study, although no useable data were provided. Data were given in a graphic presentation; no exact figures were given Study authors were contacted for additional information on 4 March 2014 and responded 10 March 2014 Declarations of interest: not stated Funding: not stated Sample size rationale: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were randomised into 2 groups" Comment: no further details given in the article. Personal communication with the study author revealed that sealed, numbered envelopes were used
Allocation concealment (selection bias)	Low risk	No details in the article about how allocation was concealed from participants and clinicians; personal communication clarified that the study author used sealed envelopes that were distributed after informed consent was obtained. Participants did not know the randomisation before signing informed consent but became aware of the allocation afterwards
Blinding of participants and personnel (performance bias) All outcomes	High risk	Observer‐blinded, but not participant‐blinded. Participants were aware of their treatment, and the study nurse who distributed study drugs was aware of the treatment arms
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "the same study investigator blindly assessed the dermatitis at various time‐points" Comment: observer‐blinded. Personal communication clarified that the study nurse was responsible for distribution of study drugs; outcomes were observed by a third person
Incomplete outcome data (attrition bias) All outcomes	Low risk	No intention‐to‐treat analysis but per protocol (26 of 32 = more than 80%)
Selective reporting (reporting bias)	Low risk	No trial registration found; no major differences between Methods and Results sections
Other bias	Unclear risk	Baseline comparisons: no baseline comparisons regarding group differences (randomisation check) Diagnostic certainty: yes The study was completed