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Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

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ClinicalTrials.gov Identifier: NCT01222000
Recruitment Status : Unknown
Verified October 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2010
Last Update Posted : October 18, 2010
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE October 12, 2010
First Posted Date  ICMJE October 18, 2010
Last Update Posted Date October 18, 2010
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2010)
  • severity of the palmar and plantar involvement [ Time Frame: J28 ]
  • level of pruritus [ Time Frame: until J28 ]
  • global tolerance and acceptability by the patient of the Polyphénon E ® ointment [ Time Frame: J28 ]
  • Relapse [ Time Frame: J84 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous
Official Title  ICMJE TREATMENT OF THE RECESSIVE NONBULLOUS CONGENITAL ICHTHYOSIS BY THE EPIGALLOCATECHINE CUTANEOUS
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lamellar Ichthyosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: right controlled against moisturizing cream
    Intervention: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
  • Experimental: left controlled against moisturizing cream
    Intervention: Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 15, 2010)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01222000
Other Study ID Numbers  ICMJE 09-PP-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chiaverini Christine, Dr CHU de Nice - Service de dermatologie
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP