Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

Lamellar Ichthyosis Clinical Trial

Official title:

TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01222000
• Other study ID #: 09-PP-02
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 12, 2010
• Last updated: October 15, 2010
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2010
• Source: Centre Hospitalier Universitaire de Nice
• Contact: chiaverini christine, Dr
• Email: chiaverini.c[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 %

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ichthyosis
• Ichthyosis, Lamellar
• Lamellar Ichthyosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Toulouse University Hospital, Dermatology Department	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	severity of the palmar and plantar involvement		J28	No
Secondary	level of pruritus		until J28	No
Secondary	global tolerance and acceptability by the patient of the Polyphénon E ® ointment		J28	No
Secondary	Relapse		J84	No