Lamellar Ichthyosis Clinical Trial
Official title:
TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS
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 %
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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