Warshaw 2007.

Methods	Study type: individual RCT Randomisation method: computer‐generated blocks of 4 Blinding: double‐blind Intention‐to‐treat analysis used: Both ITT and PP analyses were used
Participants	Inclusion criteria of the trial Facial seborrhoeic dermatitis Exclusion criteria of the trial Pregnancy or nursing Allergies to products Acne vulgaris or rosacea People with poorly controlled chronic conditions Those with cancer, neurologic conditions, or HIV infection (or other immunosuppression) Number of randomised participants: 96 in total (pimecrolimus N = 47, vehicle N = 49) Number of dropouts: 2 (2%) Sex: 85 males, 11 females Mean age (range): pimecrolimus arm = 59.5 (27 to 84) years, placebo arm = 59.6 (20 to 88) years Country: USA
Interventions	Treatment Pimecrolimus 1% cream, applied to the face twice daily for 4 weeks Comparator/s Placebo (vehicle), applied to the face twice daily for 4 weeks
Outcomes	Erythema and scaling score (scale 0 to 3) Total target area score (sum of erythema and scaling score) IGA score (Investigator's Global Assessment score, scale 0 to 4) Adverse events
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The computer‐generated randomization assignment (blocks of 4) was only accessible to the research pharmacist during the study"
Allocation concealment (selection bias)	Low risk	Quote: "The computer‐generated randomization assignment (blocks of 4) was only accessible to the research pharmacist during the study"
Similarity of the study groups (selection bias)	Unclear risk	Quote: "At baseline, both groups had similar demographics...with the exception that a higher percentage of participants in the pimecrolimus group (38%) had previously used medication to treat their seborrhoeic dermatitis, compared with participants in the vehicle group (29%). In addition, participants in the vehicle group had milder disease at baseline compared with those in the pimecrolimus group with regard to mean scale target area score...and with regard to mean facial IGA"
Blinding of participants (performance bias)	Low risk	The study was double‐blind Quote: "The two creams were packaged in identical tubes"
Blinding of care providers (performance bias)	Low risk	Quote: "double‐blind" Blinded parties were not specified. Nevertheless, the research pharmacist was the only person that knew the participants' assignments
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double‐blind" Blinded parties were not specified. Nevertheless, the research pharmacist was the only person that knew the participants' assignments
Incomplete outcome data (attrition bias) All outcomes	Low risk	The dropout rate was acceptable
Selective reporting (reporting bias)	Low risk	Prespecified outcomes were reported
Other bias	Unclear risk	Quote: "This investigator‐initiated study was supported by Novartis Pharmaceuticals Corporation" Novartis Pharmaceuticals Corporation employed at least 2 of the authors