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[Clinical trials in dermatology. The phase I trials]
J Czernielewski1, C Queille-Roussel, L Duteil
1Centre de Pharmacologie Clinique Appliquée à la Dermatologie, (C.P.C.A.D.), Hôpital Pasteur, Nice.
Therapie
|May 1, 1991
Abstract:
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.