Ignite Creation Date:
2024-05-05 @ 10:59 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01222000
Status:
UNKNOWN
Last Update Posted:
2010-10-18
First Post:
2010-10-12
Brief Title:
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 13 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None