Imiquimod for anogenital warts in non-immunocompromised adults

Grillo‐Ardila, Carlos Fernando; Angel‐Müller, Edith; Salazar-Díaz, Luis Carlos; Gaitán, Hernando; Ruíz-Parra, Ariel Iván; Lethaby, Anne

doi:10.1002/14651858.cd010389.pub2

Cited by 35 publications

(16 citation statements)

References 65 publications

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“…The positive estimation of therapeutic efficacy assessed by a doctor was observed in 52% of patients receiving Wartocid and only in 4% of patients receiving placebo. These results are in line with the results obtained when the brand product Aldara was used [9,12,19,20,22,25].…”

Section: Resultssupporting

confidence: 91%

Efficacy of Generic Drug Wartocid® (Imiquimod 5% Cream for External Use) in Anogenital Warts Treatment

Смирнов¹,

Petlenko²,

Савельев³

et al. 2017

Russian Journal of Infection and Immunity

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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/cm 2 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). Резюме. Цель. Оценка эффективности и безопасности воспроизведенного препарата Вартоцид ® (Имихимод крем 5% для наружного применения) у пациентов с наружными аногенитальными (венерическими) боро-давками (АГБ). Материалы и методы. Простое слепое сравнительное рандомизированное плацебо-контро-лируемое клиническое исследование включало 50 женщин в возрасте от 18 до 60 лет с установленным кли-ническим диагнозом АГБ в вульве и перианальном регионе. Пациенты в группе 1 получали плацебо-крем для наружного применения, тогда как пациенты в группе 2 получали терапию Вартоцидом в суточной дозе 10 мг крема/см 2 области кожи. Препарат применялся через день до полного исчезновения АГБ, но в любом

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Section: Resultssupporting

confidence: 91%

Efficacy of Generic Drug Wartocid® (Imiquimod 5% Cream for External Use) in Anogenital Warts Treatment

Смирнов¹,

Petlenko²,

Савельев³

et al. 2017

Russian Journal of Infection and Immunity

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“…For HSIL, effectiveness of IMQ is estimated to be 58% with a 16% recurrence rate. 10,[14][15][16] These data underline the need for enhanced treatment modalities. The combination treatment of IMQ with OMN may be considered as such.…”

Section: Discussionmentioning

confidence: 85%

“…9 In most of these conditions, drug efficacy is suboptimal, and lesions may re-occur after treatment discontinuation. 10 Therefore, a treatment enhancing the efficacy of IMQ in these dermatological conditions would be of great benefit. Based on its observed preclinical activity, OMN may be a good candidate for combination treatment with IMQ.…”

Section: Omiganan and Imiquimod In Skin Of Healthy Volunteersmentioning

confidence: 99%

Omiganan Enhances Imiquimod‐Induced Inflammatory Responses in Skin of Healthy Volunteers

Kolk

Assil

Buters

et al. 2020

Clinical Translational Sci

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Omiganan (OMN; a synthetic cationic peptide) and imiquimod (IMQ; a TLR7 agonist) have synergistic effects on interferon responses in vitro. The objective of this study was to translate this to a human model for proof-of-concept, and to explore the potential of OMN add-on treatment for viral skin diseases. Sixteen healthy volunteers received topical IMQ, OMN, or a combination of both for up to 4 days on tape-stripped skin. Skin inflammation was quantified by laser speckle contrast imaging and 2D photography, and molecular and cellular responses were analyzed in biopsies. IMQ treatment induced an inflammatory response of the skin. Co-treatment with OMN enhanced this inflammatory response to IMQ, with increases in perfusion (+17.1%; 95% confidence interval (CI) 5.6%-30%; P < 0.01) and erythema (+1.5; 95% CI 0.25%-2.83; P = 0.02). Interferon regulatory factor-driven and NFκBdriven responses following TLR7 stimulation were enhanced by OMN (increases in IL-6, IL-10, MXA, and IFNɣ), and more immune cell infiltration was observed (in particular CD4+, CD8+, and CD14+ cells). These findings are in line with the earlier mechanistic in vitro data, and support evaluation of imiquimod/OMN combination therapy in human papillomavirus-induced skin diseases.Cathelicidins are a family of antimicrobial (cationic) peptides that play an important role in the first line immune defense of the skin, related to their broad antimicrobial activity against bacteria, viruses, and fungi. 1 LL-37 is the only human member of the cathelicidin family. 1 Besides its antimicrobial effects, this peptide also has direct immunomodulatory activity. LL-37 affects the response of neutrophils to viruses, and modulates interferon (IFN) responses induced by viral triggers. 2 LL-37 converts self-RNA into a ligand for toll-like receptor (TLR)7 and TLR8 in human dendritic cells, thereby enhancing IFNα production in human skin. 3 Omiganan (OMN) is a synthetic indolicidin (a cathelicidin isolated from bovine neutrophils), currently under development as topical gel for several clinical indications. OMN is known to have activity against a wide variety of microorganisms, such as gram-positive and gramnegative bacteria and fungi. 4,5 Moreover, OMN enhances IFN responses induced by TLR3 (Poly:IC), TLR7 (imiquimod (IMQ)), TLR8 (ssRNA), and TLR9 (CpG) in human immune cells, comparable but not similar to the effects observed for Grievink et al.). These observations support the future application of OMN

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“…Imiquimod as an example has been reported to result in fewer adverse events compared with its currently available alternatives. However, these findings might have been affected by the low quality of the majority of studies conducted in this field [106]. It should be noted that many of these agents are novel therapeutic agents and the true incidence of serious and long-term adverse effects are not clearly known due to the rarity of these complications.…”

Section: Expert Opinionmentioning

confidence: 99%

Therapeutic targeting of Toll-like receptors in cutaneous disorders

Matin

Tabatabaie

Mohammadinejad

et al. 2015

Expert Opinion on Therapeutic Targets

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Although non-specific therapeutic strategies seem to reduce the symptoms in majority of patients, a considerable proportion remain untreated or have to deal with inevitable adverse effects of such therapies. Since TLRs regulate many patholophysiological processes, they could be good candidates for more specific therapeutic approaches. TLR targeting as the first recipient of invading pathogens is a growing concept in this field.

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Imiquimod for anogenital warts in non-immunocompromised adults

Cited by 35 publications

References 65 publications

Efficacy of Generic Drug Wartocid® (Imiquimod 5% Cream for External Use) in Anogenital Warts Treatment

Efficacy of Generic Drug Wartocid® (Imiquimod 5% Cream for External Use) in Anogenital Warts Treatment

Omiganan Enhances Imiquimod‐Induced Inflammatory Responses in Skin of Healthy Volunteers

Therapeutic targeting of Toll-like receptors in cutaneous disorders

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