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October 2003

1% Pimecrolimus Cream for Atopic Dermatitis—Reply

Author Affiliations

Not Available

Arch Dermatol. 2003;139(10):1370-1371. doi:10.1001/archderm.139.10.1369

In reply

I thank Dr Eichenfield and his colleagues for taking the trouble to provide the key information that was missing from their original clinical trial report.1 As an author and an editor, I fully understand and appreciate the pressures on authors to edit their reports drastically. Sometimes, however, this results in "throwing the baby out with the bathwater." Omitting to mention the fundamental aspects of a clinical trial report, such as describing how randomization was generated and hidden from the recruiting physicians,2 giving details on masking, and explaining whether ethical approval was obtained, makes it very difficult for a reader to judge the quality of the study: it is a bit like trying to buy a secondhand car without being shown the car's service history, tax disk, and road testing certificate. But now, thanks to the additional facts provided in Dr Eichenfield and colleagues' letter, it is clear to me that the study was well conducted, with due attention given to concealed allocation, etc. It is also now clear to me why 2 identical studies were performed and then combined, and I thank the authors for enlightening me on the Food and Drug Adminstration's regulatory approval hurdles. I would still have preferred to see the data from the 2 studies presented separately, as Hanifin et al3 managed to do in an earlier, similar study published in the same journal.