[Clinical trials in dermatology. The phase I trials].
Application of the new topical product on the diseased skin should be preceded by its safety evaluation on the healthy skin in human volunteers. We propose here guidelines for the evaluation of the irritation, sensitization, phototoxicity and photoallergy potentials for topical products. The methods for evaluation of percutaneous absorption are also discussed. The studies presented here are not the object of any regulations. Therefore, we propose here an approach for the safety evaluation of topical products in human volunteers.
Czernielewski
J
J
Centre de Pharmacologie Clinique Appliquée à la Dermatologie, (C.P.C.A.D.), Hôpital Pasteur, Nice.
Queille-Roussel
C
C
Duteil
L
L
Verschoore
M
M
Schaefer
H
H
Revuz
J
J
De Prost
Y
Y
Guillaume
J C
JC
Ortonne
J P
JP
D000287:Administration, Topical; D002986:Clinical Trials as Topic / Q000379:methods; D003880:Dermatology; D004341:Drug Evaluation / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010328:Patch Tests / Q000379:methods; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D012867:Skin / Q000378:metabolism; D012882:Skin Tests / Q000379:methods*
D004364:Pharmaceutical Preparations
Les essais cliniques en dermatologie. Les essais de phase I.