Lack of irritative potential of nadifloxacin 1% when combined with other topical anti-acne agents


  • Conflict of interest: Dr Schwantes and Dr Neumeister are employees of Dr R. Pfleger GmbH, Bamberg, Germany and Dr Zsolt is an employee of Ferrer Internacional, Barcelona, Spain.

Professor Dr Klaus-Peter Wilhelm, proDERM Institute for Applied Dermatological Research GmbH, Kiebitzweg 2, 22869 Schenefeld, Hamburg, Germany


Background.  Diverse options are available for the treatment of acne. Topical therapy is standard, especially in cases of mild to moderate acne, while the current treatments for acne vulgaris are topical keratolytics and topical antibiotics. Tolerability is a critical factor in patient compliance with topical acne therapies. The simultaneous use of more than one topical preparation with different active ingredients may cause increased irritation. However, the multifactorial aetiologies of acne, and the need to prevent development of bacterial resistance, require new acne-treatment combinations. Combining agents that target the different aetiological factors of acne can help increase efficacy and reduce response time.

Aim.  To compare the dermal irritation produced by an anti-acne cream containing 1% nadifloxacin with that produced by additional treatment with four different topical anti-acne products in a 21-day open application test in 40 healthy volunteers.

Methods.  This was a randomized, double-blind (observer-blind), single-centre, phase I clinical study with an intraindividual comparison. The topic anti-acne products (nadifloxacin, adapalene, benzoyl peroxide, azelaic acid and isotretinoin) were applied without occlusion, either alone or in combination with nadifloxacin, to the skin test areas. One test area was left untreated.

Results.  Most of the mean irritation scores were 0, and all were < 1.

Conclusions.  Combined application of nadifloxacin with any of the other four topical anti-acne products did not lead to substantial intolerance reactions compared with the effects after application of the products alone.