title: [13-cis-retinoic acid. Low dosage oral use in acne papulopustulosa. Results of a multicenter study].
abstract: Successful treatment of acne conglobata with 13-cis-retinoic acid (isotretinoin, Ro 4-3780) has already been reported in this journal [25, 36]. The aim of the present study was to treat severe forms of papulopustular acne, unresponsive to conventional therapy, with low doses of 13-cis-retinoic acid to obtain good results with few side effects. A total of 191 patients from 14 departments of dermatology in the Federal Republic of Germany received 13-cis-retinoic acid under open randomized conditions in parallel dose groups of 0.05, 0.1, and 0.2 mg/kg body weight for 20 weeks in order to establish efficacy and tolerance. All inflammatory and non-inflammatory skin lesions were counted. The intensity of seborrhea was graded by using a scale. Adverse effects as well as laboratory values were registered. After 20 weeks of treatment a 79% (0.05 mg), 80% (0.1 mg), and 84% (0.2 mg) decrease in the number of inflammatory skin lesions was seen. Fourteen patients in the lowest dose group were considered to be dropouts. The decrease in non-inflammatory skin lesions was less marked and amounted to between 49% and 69%. A significant reduction of seborrhea could be observed in all patients. The main side effect was dryness of the skin and mucous membranes, which was, however, of low intensity. The elevation of triglyceride and cholesterol levels reported with higher doses of 13-cis-acid, especially in patients with high-risk factors, were not encountered in this study.
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002986:Clinical Trials as Topic; D012628:Dermatitis, Seborrheic / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D015474:Isotretinoin; D008297:Male; D014212:Tretinoin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014212:Tretinoin; D015474:Isotretinoin
vernacular_title: 13-cis-Retinsäure. Niedrig dosierte orale Anwendung bei Acne papulopustulosa. Ergebnisse einer multizentrischen Studie.