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CLINICAL TRIALS PROFILE FOR VEREGEN

Clinical Trials for Veregen

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01082302	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	Charité Research Organization GmbH	Phase 4	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	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	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 %
Trial ID	Title	Status	Sponsor	Phase	Summary