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Last Updated: June 13, 2025

CLINICAL TRIALS PROFILE FOR VEREGEN


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All Clinical Trials for Veregen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01082302 ↗ Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage Completed Charité Research Organisation GmbH Phase 4 2010-01-01 This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01082302 ↗ Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage Completed Charité Research Organization GmbH Phase 4 2010-01-01 This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01082302 ↗ Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage Completed MediGene Phase 4 2010-01-01 This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01222000 ↗ Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous Unknown status Centre Hospitalier Universitaire de Nice Phase 3 2010-10-01 Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2). No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects. Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression. The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment. The secondary objectives - To estimate the duration of remission obtained after the treatment - To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement. - To estimate the action of cutaneous Veregen on the pruritus - And to estimate the global level of acceptability by the patient of the Veregen 10 %
NCT01490008 ↗ Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers Completed MediGene Phase 1 2011-12-01 Investigation of systemic catechin exposure following topically administered Veregen® 15% ointment in patients with external genital and perianal warts and following oral intake of a standardized green tea beverage in healthy subjects. Pharmacokinetic parameters for the main catechin EGCg used as a marker of overall catechin exposure following dermal administration in the patient group will only be calculated if sufficiently consistent data can be obtained e.g. sufficient plasma catechin concentrations to pharmacokinetically evaluate plasma profiles for plasma catechin concentrations. If applicable, a safety margin for ointment use might need to be established with respect to intolerable systemic exposures of catechins following application of Veregen® ointment. In treatment arm 1, patients with anogenital warts will apply Veregen® 15% ointment 250 mg three times daily: in the morning, at midday, and in the evening on the defined anogenital administration area (total dose of 750 mg/d) for one week . In treatment arm 2, healthy subjects will ingest 500 mL commercially available green tea beverage ("Lipton® Green Limone" distributed by PepsiCo Deutschland GmbH, Neu-Isenburg, Germany), three times daily in the morning, at midday, and in the evening (total dose of 1500 mL/d) for one week. Plasma samples will be collected to aim for a complete pharmacokinetic assessment (over 24 hours) on Days 1 and 2 at Visit 2 and on Days 7 and 8 at Visit 3 (one week after first dosing). To avoid any influence on overall systemic catechin exposure deriving from any other source than Veregen® or Lipton Green Tea, all subjects participating in the trial (patients and healthy volunteers) will be asked to follow a defined diet abstaining from food or beverages known to containing catechins (a list of all prohibited and allowed foods and beverages will be provided to all subjects). For concomitant medication, only paracetamol and oral contraceptives are allowed.
NCT02029352 ↗ Topical Green Tea Ointment in Treatment of Superficial Skin Cancer Completed Medigene AG Phase 2/Phase 3 2014-11-01 Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%). A simplified classification of BCC includes the following three histological subtypes: nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs) differ from the other subtypes as they tend to appear at a younger age, usually occur on the trunk and are often multiple. This subtype has the fastest growing incidence. A characteristic feature of BCCs is their low risk to metastasize, though if untreated they may induce considerable functional and cosmetic morbidity as they are locally invasive. Surgery is the first treatment of choice for BCC. However due to the rising incidence and the extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as they grow down from the epidermis into the superficial dermis and therefore are easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or 5-fluorouracil cream are available topical treatments for sBCC however their tumour free survival rates are not equal to the higher tumour free survival rates of surgical treatment. Next to the efficacy, the now available topical treatments are associated with local skin reactions at the treatment site, mainly erythema and erosion (imiquimod cream and 5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for additional or alternative non-invasive topical treatments. The active constituents of green tea are promising as they are supported to have anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies. The so-called polyphenols known as catechins are the active constituents of green tea and the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is thought to have a cytotoxic effect on skin cancer cells and has the availability of inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a role in inactivation of β-catenin signalling, an important component of the WNT pathway. Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the US Food and Drug Administration (FDA) for genital warts in adults. There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo for the topical treatment of sBCCs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Veregen

Condition Name

Condition Name for Veregen
Intervention Trials
Vestibulodynia 1
Female Sexual Arousal Disorder 1
Vulvodynia 1
Female Sexual Dysfunction 1
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Condition MeSH

Condition MeSH for Veregen
Intervention Trials
Warts 4
Condylomata Acuminata 3
Carcinoma 1
Sexual Dysfunctions, Psychological 1
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Clinical Trial Locations for Veregen

Trials by Country

Trials by Country for Veregen
Location Trials
United States 27
Germany 2
Netherlands 1
France 1
Guam 1
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Trials by US State

Trials by US State for Veregen
Location Trials
Texas 2
New York 2
Wisconsin 1
Washington 1
Virginia 1
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Clinical Trial Progress for Veregen

Clinical Trial Phase

Clinical Trial Phase for Veregen
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Veregen
Clinical Trial Phase Trials
Completed 5
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Veregen

Sponsor Name

Sponsor Name for Veregen
Sponsor Trials
MediGene 2
Centre Hospitalier Universitaire de Nice 1
Medigene AG 1
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Sponsor Type

Sponsor Type for Veregen
Sponsor Trials
Other 8
Industry 5
NIH 1
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Veregen: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Veregen, a topical ointment containing sinecatechins, is a treatment for external genital and perianal warts (condylomata acuminata) in immunocompetent patients 18 years and older. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Trial Design and Outcomes

Veregen's efficacy and safety were evaluated in two randomized, double-blind, vehicle-controlled studies. In these studies, patients applied the ointment three times daily for up to 16 weeks or until complete clearance of warts was achieved. The primary efficacy outcome measure was the proportion of patients who had complete clinical clearance of all warts by week 16.

  • Global Results: Treatment with Veregen resulted in a complete clearance rate of 53.6%, compared to 35.3% for the vehicle group[2][5].
  • US Results: For patients in the US alone, the response rates were 23.8% for Veregen and 0% for the vehicle group[5].

These studies demonstrated the efficacy of Veregen in treating external genital warts, making it a viable treatment option.

Market Analysis

Market Size and Demand

The market for treatments of external genital warts (EGW) is substantial, with estimates suggesting it is worth around $200 million annually. More than a million new cases of EGW are reported each year, indicating a consistent demand for effective treatments[5].

Competitive Landscape

Veregen competes with other topical treatments such as Aldara (imiquimod) from Graceway Pharmaceuticals. The marketing strategy for Veregen involves promoting it to dermatologists and OB-GYNs, who are the primary healthcare providers for patients with EGW. The sales force from Nycomed, which acquired Bradley Pharmaceuticals, plays a significant role in this effort[5].

Global Availability

Veregen is not only available in the US but also in Canada, 15 European countries, and Taiwan. Its inclusion in the 2012 European Guideline for the Management of Anogenital Warts and the US Centers for Disease Control and Prevention's 2010 Sexually Transmitted Diseases Treatment Guidelines further solidifies its market position[2].

Marketing and Promotion

Promotional Strategies

The marketing of Veregen is handled by the Doak Dermatologics and Kenwood Therapeutics divisions of Bradley Pharmaceuticals, with additional support from Nycomed's dermatology sales force. The promotional efforts include comparing the efficacy of Veregen to other marketed topical therapies like Aldara. Journal buys and in-house advertising and PR are also part of the strategy, with potential outsourcing once the acquisition by Nycomed is finalized[5].

Regulatory Approvals and Guidelines

FDA and International Approvals

Veregen has obtained market approval in several countries, including the US, Canada, and multiple European nations. It is included in the US Centers for Disease Control and Prevention's treatment guidelines for external genital warts, which enhances its credibility and market acceptance[2].

Future Projections

Market Growth

Given the consistent demand for treatments of external genital warts and the efficacy of Veregen, the market for this drug is expected to remain robust. The expansion of promotional efforts and the inclusion in international treatment guidelines are likely to contribute to its continued market presence.

Competitive Advantage

Veregen's unique active ingredient, sinecatechins derived from green tea, sets it apart from other treatments. Its safety profile and efficacy rates make it a preferred option for many healthcare providers, which should help in maintaining its market share.

Key Takeaways

  • Efficacy: Veregen has demonstrated significant efficacy in treating external genital warts, with a complete clearance rate of 53.6% in global trials.
  • Market Size: The EGW treatment market is valued at around $200 million annually, with over a million new cases reported each year.
  • Marketing Strategy: Promotional efforts are focused on dermatologists and OB-GYNs, with support from Nycomed's sales force.
  • Regulatory Approvals: Veregen is approved in multiple countries and included in international treatment guidelines.
  • Future Projections: The market for Veregen is expected to remain strong due to its efficacy, safety profile, and ongoing promotional efforts.

FAQs

What is Veregen used for?

Veregen is a topical ointment used for the treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients 18 years and older.

What are the active ingredients in Veregen?

The active ingredient in Veregen is sinecatechins, a partially purified fraction of the water extract of green tea leaves.

How effective is Veregen in treating external genital warts?

Veregen has shown a complete clearance rate of 53.6% in global trials, compared to 35.3% for the vehicle group.

Where is Veregen available?

Veregen is available in the US, Canada, 15 European countries, and Taiwan.

What are the key marketing strategies for Veregen?

The marketing strategies include promoting Veregen to dermatologists and OB-GYNs, comparing its efficacy to other treatments like Aldara, and utilizing Nycomed's dermatology sales force.

Sources

  1. Medigene AG: "Medigene's Licensee enters promotion agreement to expand Veregen® product sales in the United States"[2].
  2. MM+M: "Veregen - MM+M - Medical Marketing and Media"[5].
  3. Medigene AG: "Annual Report 2018"[3].
Last updated: 2024-12-31

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