Clinical trial NCT01222000: Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Official title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lamellar Ichthyosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 %


Eligibility criteria: 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,
* Tea intake during the trail

Primary outcomes:
measure: action and the tolerance of a daily application of topical Polyphénon E 10% ®
timeFrame: 4 weeks
Secondary outcomes:
measure: severity of the palmar and plantar involvement
timeFrame: J28
measure: level of pruritus
timeFrame: until J28
measure: global tolerance and acceptability by the patient of the Polyphénon E ® ointment
timeFrame: J28
measure: Relapse
timeFrame: J84
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital, Dermatology Department
Study officials:
affiliation: CHU de Nice - Service de dermatologie
name: Chiaverini Christine, Dr
role: PRINCIPAL_INVESTIGATOR
References: