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NCT Number: NCT07477769

Lymphocyte Phenotype of Autosomal Recessive Congenital Ichthyoses Mutated NIPAL4 (Nipal4-nEDD)

Autosomal recessive congenital ichthyoses (ARCI) are monogenic diseases of cornification that correspond to a diffuse abnormality (affecting the entire integument) of epidermal differentiation and therefore of the skin barrier. They manifest as abnormal desquamation (scaling) associated with varying degrees of inflammation (erythema). Around ten genes are currently implicated in ARCI. Nipal 4 is one of these genes, and mutations in it are found in around 1/10 of genotyped ARCI patients.

As part of this follow-up, three Nipal4 ARCI (Nipal4-nEDD) patients followed by the dermatology department of Saint-Louis hospital (Paris) were diagnosed with Sezary syndrome, a rare and serious cutaneous lymphoma (incidence 1/10,000,000), in adulthood (aged 30, 46, and 82). This lymphoma was diagnosed following a change in skin phenotype with worsening erythema, pruritus, and hyperkeratosis. The occurrence of two very rare diseases ( Nipal4-nEDD) and Sezary syndrome) in three patients raises the question of a non-coincidental association. The diagnosis of Sézary syndrome is based on a specific pathological circulating lymphocyte phenotype and is confirmed by skin histology. There is currently no obvious pathophysiological explanation for the concomitant occurrence of these two skin diseases. The blood lymphocyte phenotype of Nipal 4-nEDD patients without Sezary syndrome (SS) is unknown. A first step in investigating the mechanisms that could explain such an association would be to document this baseline lymphocyte phenotype in the Nipal 4-nEDD population without known SS.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (> 18 years old)
  • ARCI-type ichthyosis with NIPAL4 mutation (Nipal4-nEDD)

Exclusion criteria

  • Ichthyosis that has not been genotyped or with mutations in different genes
  • Patients with concomitant inflammatory, infectious, or hematological conditions
  • Individuals subject to legal protection measures or deprived of their liberty by judicial or administrative decision
  • Individuals under guardianship/curatorship
  • Opposition to the research

Treatment and study plan

Blood sampling

Other

Supplementary blood collection performed during routine venipuncture

Primary outcomes

  1. Proportion of blood lymphocyte phenotype

    Time frame: 18 months

    Description of the complete blood lymphocyte phenotype by immunophenotyping

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle Bourrat, MD

CONTACT

[email protected]

01 42 49 90 90 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Phénotype Lymphocytaire Des Ichtyoses congénitales Autosomiques récessives mutées NIPAL4 (Nipal4-nEDD)

Acronym: NIPALYMPHO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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