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Summary: In a double-blind parallel study, forty patients with dermatophytoses, verified by derect examination (KOH) and fungal culture, were treated with either sulconazole nitrate 1% cream or econazole nitrate 1% cream (20 patlents per group) twice daily for four weeks. Every patient had positive KOH and culture findings when admitted to the study; after two weeks of treatment with either medication, these results became negative for all except one member of the sulconazole group. By the end of treatment all patients had negative test results. Signs and symptoms of inflammation responded equally well to both treatments throughout the study. Of the 40 patients admitted to the study, 34 were eligible for post-study evaluation. Six patients were excluded from efficacy analyses: one had experienced an allergic reaction when treated with econazole; one had exhibited eczema following sulconazole treatment; two patients had used additional dermatological products during the post-treatment phase of the study; and two others had returned for the 10-week follow-up relapse check prior to the minimum required time. Six weeks after treatment ended, three of the 16 patients who had been treated successfully with econazole experienced relapses of their fungal infections. However, 18 of the patients who had been treated with sulconazole were still completely clear of all clinical signs of fungal infection and remained KOH and culture negative. Cosmetically, sulconazole was better accepted than was econazole. Zusammenfassung: In einer Doppelblindstudie wurden 40 Patienten mit Dermatophytosen, die durch Nativpraparate und Pilzkultur nachgewiesen waren, entweder mit 1%lger Sulconazolnitrat-oder mit 1%lger Econazolnitratcreme (20 Patienten pro Gruppe) zweimal taglich uber vier Wochen behandelt. Alle Patienten hatten zu Beginn der Untersuchung positive Ergebnisse im Nativpraparat und in der Kultur. Nach zweiwochiger Behandlung mit einem der beiden Praparate wurden diese Ergebnisse fur alle Patienten negativ mit Ausnahme eines Patienten in der Sulconazol-Gruppe. Nach Abschlus der Behandlung waren samtliche mykologischen Untersuchungsergebnisse negativ. Objektive und subjektive Symptome der Entziundung sprachen ebenso auf beide Behandlungsformen an. Von den ursprunglichen 40 Patienten konnten die Ergebnisse von 34 nach Abschlus der Behandlung ausgewertet werden. 6 Patienten musten von der Bewertung ausgeschlossen werden. Von diesen hatte ein Patient unter Econazol-Behandlung eine allergische Reaktion entwickelt. Ein Patient zeigte ein Ekzem infolge der Sulconazol-Behandlung. Zwei Patienten wendeten wahrend der Nachbehandliungsphase andere dermatologische Produkte an. Schlieslich erschienen zwei Patienten vor Ablauf der festgesetzten Nachuntersuchungszeit. 6 Wochen nach Abschlus der Behandlung zeigten drei der erfolgreich mit Econazol behandelten Patienten einen Ruckfall ihrer Pilzinfektion. Dagegen waren alle 18 Patienten, die mit Sulconazol behandelt worden waren, zum Zeitpunkt der Nachuntersuchung klinisch und mykologisch frei von Mykosen. Unter kosmetischen Aspekten wurde die Sulconazol-Zubereitung besser akzeptiert als die Econazol-Creme.

Summary: Forty patients with dermatophytoses were treated with either sulconazole nitrate 1% cream (sulconazole) or miconazole nitrate 2% cream (miconazole) twice daily for three weeks. At the start of the randomised double-blind clinical trial, all KOH and culture results were positive, and 75% of the patients were diagnosed as having tinea pedis and 25% as having other cutaneous dermatophytic infections. Follow-up visits occurred at weeks 2 and 3; all patients who were KOH negative and symptom free at week 3 returned at week 9 for a 6-week post-treatment checkup. Thirty-nine patients completed treatment One sulconazole-treated patient experienced a burning sensation the first day and was therefore withdrawn from the study; no other adverse reaction occurred. Within each treatment group, statistically significant improvement of all parameters investigated occurred at weeks 2 and 3 as compared with baseline. Sulconazole, however, proved to be more rapid in onset of therapeutic response than miconazole. At the week-2 visit, statistically significant differences in favor of sulconazole were elicited for erythema (p = 0.01), scaling (p = 0.03), itching (p = 0.03), and overall clinical improvement (p = 0.0229). Separate analysis of the tinea pedis subgroup likewise showed more rapid improvement of erythema, scaling, and itching sulconazole was used; the difference was statistically significant for overall clinical improvement (p = 0.04). At weeks 2 and 3, both groups exhibited statistically significant mycological cure rates as indicated by negative KOH and culture results. The difference in cure rates between the two groups, however, was not statistially significant A positive KOH at week 9 indicated that one miconazole-treated patient had experienced a relapse; all sulconazole-treated patients remained free of infection. Because of its more rapid onset of symptomatic improvement, sulconazole was considered to be clinically superior to miconazole in the treatment of dermatophytoses. Zusammenfassung: Vierzig Patienten mit Dermatophytosen wurden uber 3 Wochen 2mal taglich entweder mit 1% iger Sulconazolnitratcreme oder mit 2% iger Miconazolnitratcreme behandelt. Zu Begjnn der randomisierten klinischen Doppelblindstudie waren alle Nativpraparate und Pilzkulturen positiv. 75% der Patienten hatten eine Tinea pedis, 25% hatten andere Dermatophytosen der Haut. Untersuchungen fanden 2 und 3 Wochen nach Beginn der Behandlung statt. Alle Patienten mit klinischer Abheilung und negativem Nativpraparat nach 3-wochiger Behandlung kamen 9 Wochen nach Behandlungsbeginn nochmals zu einer Untersuchung 6 Wochen nach Therapieende. 39 Patienten fuhrten die Behandlung vollstandig durch. Ein Patient mit Sulconazolbehandlung fuhlte am ersten Tag ein Brennen an der Haut und wurde daher nicht weiterbehandelt. Andere unerwunschte Wirkungen wurden nicht beobachtet. Innerhalb jeder Behandlungsgruppe zeigten sich statistisch signifikante Besserungen bei alien uberpruften Merkmalen beim Vergleich zwischen dem Ausgangsbefund und den Befunden nach 2 und 3 Wochen. Unter Sulconazol setzte der therapeutische Erfolg rascher ein als unter Miconazol. Bei der Untersuchung nach 2 Wochen war ein gunstigerer Effekt des Sulconazol in bezug auf folgende Parameter festzustellen: Rotung (p = 0,01), Schuppung (p = 0,03), Juckreiz (p = 0,03), generelle klinische Besserung (p = 0,0229). Auch in der Untergruppe der Tinea pedis war ein rascheres Ansprechen von Rotung, Schuppung und Juckreiz bemerkbar. Fur die allgemeine klinische Besserung war auch hier der Unterschied statistisch signifikant (p = 0,04). Nach 2 und 3 Wochen zeigten beide Gruppen statistisch signifikante Heilungsraten, wie durch Negativwerden von Nativpraparat und Kulturen nachzuweisen war. Der Unterschied der Heilungsraten zwischen beiden Gruppen war nicht statistisch signifikant. Ein Miconzol-behandelter Patient erlitt nach 9 Wochen mit erneut positivem Nativpraparat ein Rezidiv. Alle Sulconazol-behandelten Patienten blieben erscheinungsfrei. Wegen des rascheren Einsatzes des Therapieerfolges wurde Sulconazol als Praparat gewertet, das in der Therapie von Dermatophytosen dem Miconazal klinisch uberlegen ist.

The efficacy and tolerability of topically applied oleum horwathiensis were evaluated in a double-blind, placebo-controlled study of 42 patients with chronic stable psoriasis. Both groups of patients, 19 receiving oleum horwathiensis treatment and 23 receiving placebo treatment for 12 weeks, showed clinically significant effects of treatment. Oleum horwathiensis was more effective than placebo throughout the treatment period but the difference was not statistically significant at any time. No changes in laboratory values attributable to treatment were recorded. The symptoms of the oleum horwathiensis-treated group continued to be less severe than those of the placebo-treated group throughout the 12 weeks of follow-up. The follow-up period, however, occurred partly during the summer and since the clinical status of the patients may have been affected by climate the difference between the treatment groups was not analysed statistically. The tolerability and cosmetic acceptance of oleum horwathiensis were remarkably good, and good clinical efficacy in scalp lesions – which was not the subject of this study – was spontaneously reported by several patients.

Fifty heterosexual male patients with histologically verified genital warts of short duration (less than 3 months) were randomly allocated to treatment with either 0.25% or 0.5% idoxuridine cream. The application of the cream to the warts was performed twice daily for an initial period of 14 days, whereafter patients with partial improvement or no response were retreated in the same way for another period of 14 days. Patients not completely healed after 28 days were regarded as treatment failures and withdrawn from the study. After the initial treatment period of 14 days, 19 of 25 patients (76%) treated with 0.5% idoxuridine cream, and 9 of 25 patients (36%) treated with 0.25% idoxuridine cream were completely healed. This difference is significant (p less than 0.01). The corresponding figures at the second follow-up examination (28 days after start of the study) were 19 of 25 (76%) and 13 of 25 (52%), respectively. At the last follow-up examination three months after start of treatment, four patients treated with 0.5% idoxuridine cream and five patients treated with 0.25% idoxuridine cream had a relapse. Thus, the overall rate of complete healing was 15 of 25 (60%) for the patients treated with 0.5% idoxuridine cream and 8 of 25 (32%) for those treated with 0.25% idoxuridine cream. The difference is significant (p less than 0.01). No adverse reactions were observed or reported by the patients.