Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp

Abstract

Objectives: This study investigated the non-inferiority of efficacy and tolerance of 2% miconazole nitrate shampoo in comparison with 2% ketoconazole shampoo in the treatment of scalp seborrheic dermatitis. Methods: A randomized, double-blind, comparative, parallel group, multicenter study was done. A total of 274 patients (145 miconazole, 129 ketoconazole) were enrolled. Treatment was twice-weekly for 4 weeks. Safety and efficacy assessments were made at baseline and at weeks 2 and 4. Assessments included symptoms of erythema, itching, scaling [‘Symptom Scale of Seborrhoeic Dermatitis' (SSSD)], disease severity and global change [Clinical Global Impressions (CGIs) and Patient Global Impressions (PGIs)]. Conclusions: Miconazole shampoo is at least as effective and safe as ketoconazole shampoo in treating scalp seborrheic dermatitis scalp.

Key words::

• ketoconazole shampoo
• miconazole shampoo
• seborrhoeic dermatitis
• trial registration number: DRO 2001.238.100

Acknowledgements

The study was sponsored by Drossapharm AG, Arlesheim, Basel, Switzerland. The authors would like to thank Klaus Freivogel PhD, Analytica International, D-79539 Lörrach, Germany for performing the statistical analyses. The author would like to thank Prof. Dr. Günter Burg, Zürich, for critically reviewing the manuscript and providing valuable comments and Prof. Dr. Therese Resink, Basel, for editorial assistance during the development of the manuscript. The author thank the investigators who participated in the study: Dr. Barbara Heidecker, Zürich, Dr.Andrea Cadotsch, Zürich, Dr. Martin Kägi, Zürich, Dr. Bettina Braun, Zürich, Dr. Andrea Johner, Zürich, Dr. Wolfgang Thürlimann, Zürich, Dr. Thomas Würsch, Zürich, Prof. Dr. Stephan Lautenschlager, Zürich, Dr. Siegfried Borelli, Zürich, Dr. Pierre de Viragh, Zürich, Dr. Paul Bigliardi, Schaffhausen, Dr. Ruedi Flückiger, Basel, Dr. Michael Hurni, Basel, Dr. Thomas Rakosi, Basel, Dr. Monika Weber, Basel, Dr. Elisabeth Hohenstein, Basel, Dr. Eleonora Gambillara, Basel, Dr. Oliver Philipp Kreyden, Muttenz, Prof. Dr. Lasse R. Braathen, Bern, Dr. Simone Schmid-Wienert, Bern, Dr. Clara Boudny, Bern, Dr. Eduard Kunz, Thun, Dr. Markus Rieder, Bern, Dr. Urs Sigrist, Bern, Dr. Hans Suter, Thun, Dr. Patricia Maria Inauen, Bern, Dr. Christine Frautschi, Bern, Dr. Daniel Küng, Bern, Dr. Ron Ammann, Thun, Dr. Mark Anliker, Aarau, Dr. Susanna Fistarol-Bohn, Aarau, Dr. Beat Straehl, Aarau and Dr. Vaclav Fiala, Brugg