EFFICACY OF GENERIC DRUG WARTOCID® (IMIQUIMOD 5% CREAM FOR EXTERNAL USE) IN ANOGENITAL WARTS TREATMENT

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Abstract

Aim. To evaluate the efficacy and safety of the generic drug Wartocid® (Imiquimod cream 5% for external use) in patients with external anogenital (venereal) warts (AGW).

Materials and methods. The single-blind comparative, randomized, placebo-controlled clinical trial included 50 women aged 18 to 60 with an established clinical diagnosis of AGW in the vulva and perianal region. Patients in group 1 received placebo cream for external use, while patients in group 2 received therapy with Wartoсid in a daily dose of 10 mg cream/cm2  of skin area. The drug was applied every other day until the complete disappearance of AGW, but in any case, not more than 16 weeks. A follow-up was carried out for 4 more weeks. The study evaluated the dynamics of subjective and objective symptoms, the presence and the frequency of relapses, and the percentage of full treatment of AGW.

Main results. Treatment with Wartoсid resulted in a complete cure of AGW in 16% of patients, and a reduction in the focus area of AGW in 36% of patients. Against the background of the placebo no dynamics of the disease were reached. Neither serious adverse events nor clinically significant changes in blood tests, urine or serum biochemical parameters in any of the patients who received treatment with Wartoсid were observed.

Conclusion. The generic drug Wartocid has been proved to be effective and safe for AGW treatment and its effectiveness is similar to the original drug Aldara® (Imiquimod cream 5% for external use).

About the authors

V. S. Smirnova

CJSC MBSIK “Cytomed”

Author for correspondence.
Email: vssmi@mail.ru

Vyacheslav S. Smirnov - PhD, MD (Medicine), Professor, Head Researcher.

191025, St. Petersburg, Muchnoy lane, 19, Phone: +7 (911) 948-59-22 (mobile)

Russian Federation

S. V. Petlenkoa

CJSC MBSIK “Cytomed”

Email: fake@neicon.ru

PhD, MD (Medicine), Senior Researcher, Head of the Department of Clinical Trials.

St. Petersburg

Russian Federation

S. A. Savelyeva

CJSC MBSIK “Cytomed”

Email: fake@neicon.ru

PhD (Biology), Officer of the Registration Department.

St. Petersburg

Russian Federation

G. Redlichb

Implicit Bioscience

Email: fake@neicon.ru

CEO & Managing Director.

Brisbane

Australia

N. I. Stukana

CJSC MBSIK “Cytomed”

Email: fake@neicon.ru

Officer of the Department of Clinical Trials.

St. Petersburg

Russian Federation

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Copyright (c) 2017 Smirnova V.S., Petlenkoa S.V., Savelyeva S.A., Redlichb G., Stukana N.I.

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