Biomaterial Database

[Acne therapy with isotretinoin in dermatologic practice. A multicenter phase IV study of 788 patients]. 1988

W Meigel, and A Mack-Hennes

Dermatologischen Abteilung, Allgemeinen Krankenhauses St. Georg, Hamburg.

In a multicenter study, 788 patients suffering from severe acne resistant to therapy were treated with isotretinoin by 758 dermatologists in private practices. The study was conducted using standardized test forms and questionnaires. The goal of the study was to establish the risk/benefit ratio of the drug, if it was applied to patients of a dermatological practice. The initial daily dose amounted to 0.5 mg/kg body weight, the time of treatment was 12 to 16 weeks. The clinical efficacy was judged very good or good by 90% of the doctors and patients. The kind, frequency, and intensity of the side effects observed corresponded with those found in previous studies conducted at hospitals. Our critical analysis of the results left no doubt about the therapeutic value and the safety of isotretinoin, if it is used by dermatologists in private practices.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004305	Dose-Response Relationship, Drug	The relationship between the dose of an administered drug and the response of the organism to the drug.	Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D005260	Female		Females
D005500	Follow-Up Studies	Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.	Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000152	Acne Vulgaris	A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors.	Acne
D000293	Adolescent	A person 13 to 18 years of age.	Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328	Adult	A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available.	Adults