NCT01222000

Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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 %

Conditions

• Lamellar Ichthyosis

Interventions

Type	Name	Description
DRUG	apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side	After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.
DRUG	apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side	After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-10-18
• Last updated: 2010-10-18

Locations

1 site across 1 country: France