VEREGEN SUMMARY
Veregen™ is a botanical drug product for topical use. The drug substance in Veregen™ is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i. e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.
Veregen™ is indicated for the topical treatment of external genital and perianal warts (C ondylomata acuminata) in immunocompetent patients 18 years and older.
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NEWS HIGHLIGHTS
Published Studies Related to Veregen (Sinecatechins Topical)
Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. [2008.06]
OBJECTIVE: To estimate the clinical efficacy of topical sinecatechins, a defined green tea extract, in the treatment of external genital and perianal warts... CONCLUSION: Topical sinecatechins ointments 15% and 10% are effective and well-tolerated in the treatment of anogenital warts. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00449982. LEVEL OF EVIDENCE: I.
A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts. [2010.03]
Abstract Objective: To evaluate the cost-effectiveness and treatment-cost impact of sinecatechins (Veregen * ) as first-line therapy against its principal comparator, imiquimod (Aldara dagger ), in the treatment of external genital warts (EGWs). Method: A two-stage decision model is proposed to compare sinecatechins with its principal comparator, imiquimod, as a first-line topical therapy in the treatment of EGWs.
Clinical Trials Related to Veregen (Sinecatechins Topical)
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]
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.
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment [Completed]
External Genital Warts (EGW) are the most common sexually transmitted disease associated
with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective
method of EGW treatment. However, multiple sessions may be required with reported clearance
rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration
approved for three times daily application in immunocompetent subjects 18 years and older
for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by
sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with
immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy,
treating both clinical and sub-clinical lesions. For this study, the investigators used
sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect
with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also
anticipated that the sequential therapy with be safe.
Topical Green Tea Ointment in Treatment of Superficial Skin Cancer [Recruiting]
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.
Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage [Completed]
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.
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous [Not yet recruiting]
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 %
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Page last updated: 2010-10-05
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