RESUMO
BACKGROUND AND METHODS: Because acne is androgen dependent, antiandrogen therapy might improve the condition. Inocoterone acetate (RU 882) is a nonsteroidal antiandrogen that binds to the androgen receptor and has antiandrogenic activity in animal models. To test its topical effect on acne, 126 male subjects with facial acne completed a 16-week, multi-center, double-blind study in which the twice-daily application of a 10% solution of inocoterone was compared with vehicle solution. Baseline and monthly examinations included acne lesion counts and general and endocrine laboratory tests. RESULTS: Inflammatory papules and pustules showed greater reduction in the inocoterone-treated subjects than in the subjects treated with vehicle. This difference achieved statistical significance by week 12 (24% reduction vs 10%) and week 16 (26% reduction vs 13%) and, with longitudinal analysis, throughout the course of the study. Global assessments and changes in comedo counts and sebum excretion rates were not significantly different between the groups. No serious adverse reactions were encountered. CONCLUSIONS: In this double-blind study of 126 male subjects with acne, a topical solution of the antiandrogen inocoterone, compared with vehicle, produced a modest but statistically significant reduction in the number of inflammatory acne lesions.
Assuntos
Acne Vulgar/tratamento farmacológico , Indenos/uso terapêutico , Administração Tópica , Adulto , Método Duplo-Cego , Humanos , Indenos/administração & dosagem , MasculinoRESUMO
Considerations in design and analysis of clinical trials in atopic dermatitis are discussed. Since studies analyzed statistically provide an impression of the "probable" effect on the "average" patient, the value of the conclusions depends on the limits imposed by the investigator(s) on factors such as sample size, heterogeneity of the patient population, relevance of the parameters measured and biases introduced in data collection and management. Suggestions are provided for inclusion/exclusion criteria, variables to be measured, sign/symptom scoring systems and data presentations in studies involving patients with atopic dermatitis.
Assuntos
Dermatite Atópica/tratamento farmacológico , Projetos de Pesquisa , Viés , Ensaios Clínicos como Assunto , Coleta de Dados , Humanos , Distribuição AleatóriaAssuntos
Antifúngicos/farmacologia , Piridonas/farmacologia , Anti-Inflamatórios não Esteroides/farmacologia , Antifúngicos/farmacocinética , Antifúngicos/uso terapêutico , Ciclopirox , Dermatomicoses/tratamento farmacológico , Humanos , Testes de Sensibilidade Microbiana , Piridonas/farmacocinética , Piridonas/uso terapêutico , Absorção CutâneaRESUMO
Axenic cultures of normal, habituated and crown gall teratoma were grown under varying conditions to examine the effects of environment on the expression of neoplastic character. Acid phosphatase patterns on polyacrylamide gels did not vary greatly among tissues although there were differences in acid phosphatase activity between various strains of Agrobacterium tumefaciens, the bacteria which cause crown gall. Certain esterase isoenzymes were found only in tissues grown on specific media, while others were tissue-specific but independent of the nature of the medium. Comparisons of liquid and solid grown cultures revealed that culture conditions also influence esterase expression. Both sunflower and tobacco crown gall tissue contained an esterase not found in habituated or normal tissues, and similar in electrophoretic mobility to an esterase found in extracts of the bacteria that had induced the tumors. The basic difference between the three tissue types studied is the manner in which they respond to a given environment.
Assuntos
Fosfatase Ácida/metabolismo , Esterases/metabolismo , Isoenzimas/metabolismo , Nicotiana/enzimologia , Tumores de Planta/enzimologia , Plantas Tóxicas , Transformação Celular Neoplásica , Técnicas de Cultura , Tumores de Planta/etiologia , Rhizobium/enzimologiaRESUMO
The authors have improved and simplified previous methods for producing localized mycotic skin infections in an attempt to compare topical antifungal agents for their bioequivalency. Healthy human volunteers who had negative results for commercial, purified Trichophyton antigen (Trichophytin) were inoculated with Trichophyton mentagrophytes on two sites on each forearm in a randomized study designed to compare the antifungal activities of two ciclopirox olamine formulations. The lesions, easily induced by the authors' method, were localized and did not spread under the occlusive dressings. Infections established at the four sites on 26 subjects were treated twice daily for 14 days with the two active drug formulations and their vehicles. There were no significant differences in culture-documented cure rates or alleviation of clinical signs and symptoms between ciclopirox olamine lotion and cream. Each drug was significantly better than its vehicle. The authors' method seems to be effective and suitable for therapeutic studies.
Assuntos
Antifúngicos/uso terapêutico , Piridonas/uso terapêutico , Tinha/tratamento farmacológico , Trichophyton/efeitos dos fármacos , Adulto , Antifúngicos/administração & dosagem , Ciclopirox , Feminino , Humanos , Masculino , Modelos Biológicos , Pomadas , Piridonas/administração & dosagem , SuspensõesRESUMO
A mutant strain of Saccharomyces cerevisiae (D10-ER1) has been isolated after a two-step mutagenesis of strain 4059-358D (SUC 1) using ethyl methane sulfonate. Cells of this new strain produced a level of total invertase equaling that of 4059 but contained only trace amounts of the small, internal, aglycan form of the enzyme (less than 0.1% of total in D10-ER1 compared with 6% in 4059). When D10.ER1 was crossed with an invertase-hyperproducing strain dgr3 (SUC3), progeny were isolated (HZ400-5A and HZ400-2C) in which levels of total invertase had at least quadrupled. The percentage of small invertase, however, remained insignificant. Levels of small invertase in strain HZ400-5A were determined by affinity chromatography on conconavalin A-Sepharose, gel permeation chromatography, and isopycnic centrifugation in CsCl. The large invertase of the SUC1 yeasts described here was found to contain a form apparently greater in size than the large invertase of the SUC2 strain FH4C; this probably reflects a higher content of carbohydrate. The overall results of this study do not support a direct structural relationship between large and small invertases. The implications on invertase biosynthesis and structure are discussed.