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NCT02081313 Clinical Trial

Natural History and Biological Study of Netherton Syndrome

Healthy Clinical Trial

— NSnatbio  

Official title:
Syndrome de Netherton : Aspects Cliniques, Physiopathologiques et Identification de Cibles thérapeutiques

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02081313
Other study ID # C12-56
Secondary ID 2013-A00275-40
Status Recruiting
Phase N/A
First received March 5, 2014
Last updated February 3, 2015
Start date April 2014
Est. completion date November 2017

Study information
Verified date February 2015
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Alain Hovnanian, MD, PhD
Phone 33142754289
Email alain.hovnanian@inserm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

This study aims at studying the natural history of Netherton syndrome (NS), to identify the consequences of LEKTI deficiency on the immune system and to characterize new molecular mechanisms involved in the disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 2017
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Adult or child (no age limit)

- Confirmed diagnosis of Netherton syndrome

- Signed informed consent form for the patient or his legal representative

Exclusion Criteria:

- Bleeding disorder precluding skin biopsy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Other:
• Biopsy

• Blood sample

Locations
Country Name City State
France Imagine Institute for genetic diseases Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of seric cytokines levels 3 months after patient recruitment No
Secondary Pattern of skin abnormalities 3 months after patient recruitment No
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