Lack of irritative potential of nadifloxacin 1% when combined with other topical
anti-acne agents.
Author(s): Wilhelm KP, Wilhelm D, Neumeister C, Zsolt I, Schwantes U.
Affiliation(s): proDERM Institute for Applied Dermatological Research GmbH, Schenefeld, Hamburg,
Germany. kpw@proderm.de
Publication date & source: 2012, Clin Exp Dermatol. , 37(2):112-7
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.
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