[Oxatomide in the treatment of pruriginous skin diseases of various nature].
A study in two parts was carried out with the aim of developing a formulation of oxatomide for topical dermatological use. During the first part of the study the safety of 4 formulations (cream and gel at 2.5% and 5%) was evaluated by means of the patch-test, while in the second a clinical trial was carried out in order to assess the anti-itching efficacy of the formulation chosen on the basis of the results of the first part (gel 5%). During the double blind study of safety, only one patient out of 33 studied showed a reaction, and with all formulations. In the second part of the study 30 patients (16 F, 14 M) were admitted, aged between 13 and 77 years (mean age 48.2) and suffering from cutaneous diseases with itching. The study was open and each subject applied oxatomide gel at 5% twice a day for 14 days. There was a subsequent follow-up without therapy of 14 days. During the study a significant (p less than 0.01 between times) improvement in lesions was observed, with an average reduction of 61% for itching, 54% for erythema, 60% for excoriations and 59% for lichenification. Acceptability and safety were good. Only one subject suspended treatment due to the onset of burning on the site of application. In the follow-up period the therapeutic results achieved were generally maintained.
Lodi
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Ospedale S. Paolo, Cattedra di Clinica Dermosifilopatica, Università degli Studi di Milano.
Urbani
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CE
Nicora
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011536:Prurigo / Q000188:drug therapy*; D012871:Skin Diseases / Q000188:drug therapy*; D013997:Time Factors
D006634:Histamine H1 Antagonists; D009824:Ointments; D010879:Piperazines; C015408:oxatomide