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History of Changes for Study: NCT01222000
Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Latest version (submitted October 15, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 15, 2010 None (earliest Version on record)
Comparison Format:

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Study NCT01222000
Submitted Date:  October 15, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 09-PP-02
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2010
Overall Status: Unknown status [Previously: Not yet recruiting]
Study Start: October 2010
Primary Completion: June 2011 [Anticipated]
Study Completion: June 2011 [Anticipated]
First Submitted: October 12, 2010
First Submitted that
Met QC Criteria:
October 15, 2010
First Posted: October 18, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 15, 2010
Last Update Posted: October 18, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Centre Hospitalier Universitaire de Nice
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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 %
Detailed Description:
Open or close this module Conditions
Conditions: Lamellar Ichthyosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 8 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. severity of the palmar and plantar involvement
[ Time Frame: J28 ]

2. level of pruritus
[ Time Frame: until J28 ]

3. global tolerance and acceptability by the patient of the Polyphénon E ® ointment
[ Time Frame: J28 ]

4. Relapse
[ Time Frame: J84 ]

Open or close this module Eligibility
Minimum Age: 8 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Chiaverini Christine, Dr
Principal Investigator
CHU de Nice - Service de dermatologie
Locations: France
Toulouse University Hospital, Dermatology Department
Toulouse, France
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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