Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

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 %

Study Overview

• Status: Unknown
• Conditions: Lamellar Ichthyosis
• Intervention / Treatment: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Toulouse University Hospital, Dermatology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: right controlled against moisturizing cream	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.
Experimental: left controlled against moisturizing cream	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
action and the tolerance of a daily application of topical Polyphénon E 10% ®	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.	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Chiaverini Christine, Dr, CHU de Nice - Service de dermatologie

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): October 18, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Abnormalities; Keratosis; Ichthyosis; Ichthyosis, Lamellar; Ichthyosiform Erythroderma, Congenital
• Other Study ID Numbers: 09-PP-02