Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Summary
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 %
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Lamellar Ichthyosis
Intervention
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side, apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
Location
Toulouse University Hospital, Dermatology Department
Toulouse
France
Status
Not yet recruiting
Source
Centre Hospitalier Universitaire de Nice
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01222000
- Information obtained from ClinicalTrials.gov on November 11, 2010
Medical and Biotech [MESH] Definitions
Ice Cream
A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.
Area Postrema
A small, rounded eminence on each side of the FOURTH VENTRICLE, which receives nerve fibers from the SOLITARY NUCLEUS; SPINAL CORD; and adjacent areas of the MEDULLA OBLONGATA. The area postrema lies outside the BLOOD-BRAIN BARRIER and its functions include acting as an emetic chemoreceptor.
Anastomosis, Surgical
Surgical union or shunt between ducts, tubes or vessels. It may be end-to-end, end-to-side, side-to-end, or side-to-side.
Skin Window Technique
A technique to study CELL MIGRATION in the INFLAMMATION process or during immune reactions. After an area on the skin is abraded, the movement of cells in the area is followed via microscopic observation of the exudate through a coverslip or tissue culture chamber placed over the area.
Hip
The projecting part on each side of the body, formed by the side of the pelvis and the top portion of the femur.
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