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C Queille-Roussel

Publications and source records attributed to C Queille-Roussel.

23 records · Page 2Linked to original sources

[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.

Administration, Topical↗

[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.

Administration, Topical↗

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical antipsoriatic treatment].

There has been considerable variations between different authors in the evaluation of antipsoriatic therapies. Improvement homogeneity must be achieved in this field. The main specific methods have been investigated: inclusion criteria, assessment of disease progress and safety parameters in phase II and III clinical trials, evaluating antipsoriatic treatment.

Administration, Topical↗

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical antifungal agent in the treatment of superficial mycoses].

There is no single method for evaluating topical antifungal drugs. The localisation and the type of fungal, determine the treatment duration (from few days to several months). The main methodological characteristics of clinical trials in tinea pedis treatment (athlete's foot type) are reported. Aspects related to other clinical forms such as tinea versicolor and onychomycosis are also described. In any case, the main criteria of activity remains the mycological examination based on KOH microbiology and culture performed at the end of the treatment and again afterwards.

Administration, Topical↗