Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Primary Purpose
Lamellar Ichthyosis
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
Sponsored by
About this trial
This is an interventional treatment trial for Lamellar Ichthyosis
Eligibility Criteria
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
Sites / Locations
- Toulouse University Hospital, Dermatology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
right controlled against moisturizing cream
left controlled against moisturizing cream
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
severity of the palmar and plantar involvement
level of pruritus
global tolerance and acceptability by the patient of the Polyphénon E ® ointment
Relapse
Full Information
NCT ID
NCT01222000
First Posted
October 12, 2010
Last Updated
October 15, 2010
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01222000
Brief Title
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Official Title
TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
5. Study Description
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 cutaneous Veregen on the pruritus
And to estimate the global level of acceptability by the patient of the Veregen 10 %
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lamellar Ichthyosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
right controlled against moisturizing cream
Arm Type
Experimental
Arm Title
left controlled against moisturizing cream
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
Intervention Description
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.
Primary Outcome Measure Information:
Title
action and the tolerance of a daily application of topical Polyphénon E 10% ®
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
severity of the palmar and plantar involvement
Time Frame
J28
Title
level of pruritus
Time Frame
until J28
Title
global tolerance and acceptability by the patient of the Polyphénon E ® ointment
Time Frame
J28
Title
Relapse
Time Frame
J84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chiaverini christine, Dr
Email
chiaverini.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiaverini Christine, Dr
Organizational Affiliation
CHU de Nice - Service de dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital, Dermatology Department
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
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