Clinical Trial: Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

Official Title: TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

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 cutaneou

    Detailed Summary:
    Sponsor: Centre Hospitalier Universitaire de Nice

    Current Primary Outcome: action and the tolerance of a daily application of topical Polyphénon E 10% ® [ Time Frame: 4 weeks ]

    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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • severity of the palmar and plantar involvement [ Time Frame: J28 ]
    • level of pruritus [ Time Frame: until J28 ]
    • global tolerance and acceptability by the patient of the Polyphénon E ® ointment [ Time Frame: J28 ]
    • Relapse [ Time Frame: J84 ]


    Original Secondary Outcome: Same as current

    Information By: Centre Hospitalier Universitaire de Nice

    Dates:
    Date Received: October 12, 2010
    Date Started: October 2010
    Date Completion: June 2011
    Last Updated: October 15, 2010
    Last Verified: October 2010