A Phase 3 interventional study of apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side and apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side in Lamellar Ichthyosis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 3, Interventional, and Treatment
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
20 studies on the registry are indexed under Ichthyosis, Lamellar; 2 are open to participants now.
This study's enrollment of 6 is below the median of 20 across 14 interventional studies indexed under Ichthyosis, Lamellar.
Browse Ichthyosis, Lamellar studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Drug: apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side
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.
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.
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.
Time frame: 4 weeks
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
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice