Effectiveness and Tolerance of Topical Nadifloxacin in the Therapy of Acne Vul- garis (grade I-II): Results of a Non-inter- ventional Trial in 555 Patients

Regulatory approval of topical nadifloxacin for the treatment of acne vulgaris was based on data from controlled and randomised clinical trials using a monotherapy regimen. Frequently in dermatological practice, however, multi-regimen approaches are used. This prospective trial was conducted to assess clinical use and value of topical nadifloxacin in the treatment of acne vulgaris under routine conditions. A non-interventional trial was performed in 105 dermatological practices in Germany. Inclusion criteria were the presence of acne papulo-pustulosa (acne vulgaris grade I-II)1 and the indication of therapy with nadifloxacin. In addition to treatment characteristics, cardinal disease symptoms and quality of life data were recorded before and after therapy with nadifloxacin. Investigators and patients were asked to rate effectiveness and tolerance of therapy. Data was evaluated in an exploratory sense. Five hundred fifty five of 589 data sets fulfilled the criteria for evaluation. Mean patient age was 21.3 and patients had a mean history of acne vulgaris of approximately 33 months. 68.5% of the patients received nadifloxacin as monotherapy, 27% had an additional topical treatment, and in 10.3%, systemic medication was also administered. After a mean treatment period of 50.8 days dermal symptoms had significantly diminished. In 81.3% of the whole trial population, the investigators rated the effectiveness as “very good/good”. A slightly better appraisal was obtained for nadifloxacin monotherapy (82.1%) while efficacy assessment for the combination of nadifloxacin and additional topical therapy was slightly inferior (77.5%). The patient rating for the concomitant administration of systemic medication was comparable to nadifloxacin monotherapy (82.4%). The reduction of dermal symptoms was Effectiveness and Tolerance of Topical Nadifloxacin in the Therapy of Acne Vulgaris (grade I-II): Results of a Non-interventional Trial in 555 Patients Helmut Schöfer1 Arno Göllner3 Werner Kusche2 Ulrich Schwantes3 1Centre of Dermatology and Venerology, Johann-Wolfgang-Goethe University Clinic, D-60590 Frankfurt 2A.CRO Clinical Research Services GmbH, D-65191 Wiesbaden 3Dept. Medical Science/Clinical Research, Dr. R. Pfleger GmbH, D-96045 Bamberg