Clinical efficacy, safety and tolerance of the Kerawort (imiquimod) cream used for treatment of anogenital warts

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Abstract

Goal of the study. To assess the efficacy and safety of Kerawort (Imiquimod, 5% cream for topical administration) vs. placebo used for treatment of anogenital warts. Methods and materials. The single-blind comparative placebo-controlled study involved 90 patients (44 female and 46 male) with anogenital warts. The patients were randomized into two groups: the main group (n = 45) receiving treatment with Kerawort (Imiquimod, 5% cream) and the control group (n = 45) receiving placebo. The diagnosis was confirmed by the identification of human papillomavirus by the polymerase chain reaction method. The patients received treatment three times a week until clinical signs disappeared but for not more than 16 weeks. Results. In 95.6% of patients from the main group and 8.9% of patients from the control group, anogenital warts disappeared completely or the quantity/area of pathological eruptions reduced at least by 70% as compared to the baseline. No relapses occurred during the treatment and follow-up period (28 days after the completion of treatment) in patients from the main group. An increase in the size and/or area of anogenital warts and/or development of new eruptions on the skin and mucous membrane of the genitals were recorded in 11.1% of patients from the control group. No serious adverse events were revealed during the study. Conclusion. Higher efficacy (р < 0.0000001) and comparable safety of Kerawort (Imiquimod, 5% cream for topical administration) used for treatment of anogenital warts vs. placebo were reliably established.

About the authors

M. R. Rakhmatulina

State Research Center of Dermatovenereology and Cosmetology, Ministry of Healthcare of the Russian Federation

Author for correspondence.
Email: rahmatulina@cnikvi.ru
Россия

A. A. Kubanov

State Research Center of Dermatovenereology and Cosmetology, Ministry of Healthcare of the Russian Federation

Email: noemail@neicon.ru
Россия

A. V. Samtsov

Military Medical Academy named after S.M. Kirov Ministry of Defense of the Russian Federation

Email: noemail@neicon.ru
Россия

A. V. Sukharev

Military Medical Academy named after S.M. Kirov Ministry of Defense of the Russian Federation

Email: noemail@neicon.ru
Россия

O. I. Bondar

Military Medical Academy named after S.M. Kirov Ministry of Defense of the Russian Federation

Email: noemail@neicon.ru
Россия

A. V. Semenenko

Russian Medical Academy of Postgraduate Studies, Ministry of Health of the Russian Federation

Email: noemail@neicon.ru
Россия

References

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  2. Kacambas A.D., Lotti T.M. Evropejskoe rukovodstvo po lecheniju dermatologicheskih boleznej: MEDpress-inform 2009; 8-9.
  3. Rakhmatulina M.R. New potential of the complex therapy of anogenital papilloma viral infection.Vestn Dermatol Venerol 2011; 2: 79-84.
  4. Molochkov V.A., Kiselev V.l., Rudyh I.V. i dr. Papillomavirusnaja infekcija. M: Mirada Viva 2008.
  5. Dubenskij V.V. Kliniko-jepidemiologicheskie osobennosti papillomavi-rusnoj infekcii i metody lechenija. Ros zhurn kozh ven bol 2001; 1: 51-56.
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  7. Rogovskaja S.l. Papillomavirusnaja infekcija u zhenshhin i patologija shejki matki. M: GJeOTAR-Media 2008.

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Copyright (c) 2015 Rakhmatulina M.R., Kubanov A.A., Samtsov A.V., Sukharev A.V., Bondar O.I., Semenenko A.V.

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