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H Schaefer

Publications and source records attributed to H Schaefer.

172 records · Page 10Linked to original sources
PubMedDate not supplied

[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↗
PubMedDate not supplied

[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↗
PubMedDate not supplied

[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↗
PubMedDate not supplied

[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↗
PubMedDate not supplied

[Clinical trials in dermatology. Statistical support].

To determine the efficacy or safety of new topical treatments, more or less standardized studies must be performed. This article presents several examples of statistical analyses of the data currently seen in the dermatology area, and some guidelines for study sample size determination. More importantly, it indicates, for as soon as phase I studies, the need for preliminary informations such as development strategy, historical data, literature references or pilot studies, to determine or adapt appropriate designs and sample sizes. This need can be filled by close collaboration among clinicians, statisticians and sponsor.

Clinical Trials as Topic↗
PubMedDate not supplied

[Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical anti-acne].

Acne is a frequent dermatologic disease of the teenagers. Methodology of antiacne preparations clinical trials has evolved recently, leading to better comprehension of acne treatment on acne lesions. The main rules for good clinical evaluation of acne treatments are: an objective counting of each individual lesions on a defined area (face, back), a global acne assessment, a therapy duration from 1 to 3 months or more, a skin safety evaluation for erythema, desquamation, dryness, itching, burning and oiliness with a 0 to 3 scoring system.

Acne Vulgaris↗
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[Aging and dying--reflections on statistical figures].

Aging and death of man have changed decisively during the last centuries. Today, three age-dependent mortalities can be distinguished: the mortalities in the early years of life, those caused by external forces, and the rest of mortality. The logarithm of the rest of mortality is, starting with the 20th year of life, relatively strictly correlated to age. Only this age-dependent mortality can be regarded as a "natural" mortality. It is however enabled only by a culturally and technically extremely favorable environment. The slope of the age-dependent mortality is relatively stable geographically and in the course of time, and is nearly equal for both sexes. Of various diseases, their relative mortalities (expressed in percent of total mortality) indicates an age-specific susceptibility for the causes of death, with high percentages either in youth, in midlife or in high age. The mortality of all cancers was relatively stable during the last decades, whereas the specific mortalities of different cancer sites varied to a much higher degree ("vicarious mortality"). Death is programmed relatively rigidly, as far as it is not related to violence (accidents, poisoning, murder). Perhaps the genetical determination is prevailing. The slope of the programmed part of mortality of woman changes in its steepness after the age of 60, with an increasing rate of mortality.

Adolescent↗
PubMedDate not supplied

[Occupation and illness].

1. There are three kinds of work-related diseases: officially recognised occupational diseases; occupational diseases; work-related but unspecific diseases. 2. These unspecific diseases occur more often than would be by mere chance, among certain professional groups. 3. Cancer mortality may increase as a result of occupational cancer-promoting factors, whereas the overall mortality may be unaffected. 4. In such cases, the mortality of other diseases not related to the occupation, is diminished ("vicarious mortality"). 5. The overall cancer mortality is probably not greatly increased by professional influences. This mortality is nearly constant in males and tends to decrease in females. 6. A strong inequality of mortality rates has been found in various occupational groups. The reason for these discrepancies is unknown. 7. Mortality is most strongly related to the mental demands made on individuals by their profession. 8. Death through accidents is six times more frequent in the general population compared with job-related accidents. 9. Health hazard due to occupation is low in relation to mortality, but marked in work-related diseases.

Accidents, Occupational↗