[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical anti-inflammatory treatment in atopic dermatitis].
Study designs for assessment of topical anti-inflammatory drugs in atopic dermatitis are discussed. Atopic dermatitis is a chronic disease with symmetrically distributed lesions. In order to avoid individual and spontaneous variation and to obtain an early impression of the efficacy of a new topical drug, bilaterally paired lesions can be used. Further drug development requires controlled double-blind parallel group design. General recommendations regarding inclusion criteria, and the measurement of efficacy and safety parameters are presented. Methods available for data evaluation and the particularities of different clinical designs are discussed.
Queille-Roussel
C
C
Centre de Pharmacologie Clinique Appliquée à la Dermatologie, (C.P.C.A.D.), Hôpital Pasteur, Nice.
Dahan
C
C
Poncet
M
M
Schaefer
H
H
Revuz
J
J
De Prost
Y
Y
Guillaume
J C
JC
Ortonne
J P
JP
Czernielewski
J
J
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004341:Drug Evaluation / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male
D000893:Anti-Inflammatory Agents
Les essais cliniques en dermatologie. Evaluation de la tolérance et de l'efficacité d'un traitement anti-inflammatoire topique dans le traitement de la dermatite atopique.