CompletedPhase 3

Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

France6 participantsStarted 2010-10

Plain-language 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 %

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients of both sexes of at least 8 years and less than 65 years. * Patients with a clinical diagnosis of LI * Patients having at once a score of roughness and a desquamation of intensity moderated in severe (at least 2) on every side of the body, * Patients and\\or relatives / representatives of the parental authority in measure to understandand to follow the procedures of the study * Consent of patient and\\or parents / representatives of the parental authority * Patient member to the Social Security Exclusion Criteria: * Patient of less than 8 years * Pregnant, breast-feeding women or old enough to procreate without reliable medical contraception, * Women with a positive pregnancy test, * Transaminases \> twice the normal. * Patients with congenital ichthyosis others than LI, * Patients with a erythrodermic composent, * Patients affected by LI of the light gravity (score \< 2 for the desquamation or the roughness) on at least a side of the body, * Patients with secondary infection , * Patients with known allergy of to one of the ingredients contained in the tested product, * Patients with specific topical treatment (for example analogues of vitamin A, vitamin D similar), * Patients with topical keratolytic treatment (for example the urea, the hydroxy-acids) in 7 days before the beginning of the clinical trial * Patients and\\or relatives / representatives of the parental authority unable to understand and\\or to follow the procedures of the study,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

action and the tolerance of a daily application of topical Polyphénon E 10% ®

Timeframe: 4 weeks

Trial details

NCT IDNCT01222000

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03-25

View on ClinicalTrials.gov More Lamellar Ichthyosis trials