Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patients Treated With Dupilumab (CYCLADDE)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Atopic Dermatitis; Conjunctival Diseases; Side Effect

Treatments: Other: Tears sampling; Other: Lashes sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04066998

P/2019/424

Details and patient eligibility

About

This study aims to assess the cytokine profile of tears in patients suffering from conjunctivitis versus patients without ocular involvement, when treated with Dupilumab

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with severe atopic dermatitis resistant to main immunosuppressive drugs
• treated with Dupilumab
• with or without conjunctivitis
• postmenopausal women (since minimum 24 months), surgically sterilized women or women on contraception

Exclusion criteria

• pregnant or breastfeeding women

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Conjunctivitis

Experimental group

Description:

Patients treated with Dupilumab with conjunctivitis

Treatment:

Other: Lashes sampling

Other: Tears sampling

No conjunctivitis

Other group

Description:

Patients treated with Dupilumab and showing no signs of ocular involvement

Treatment:

Other: Lashes sampling

Other: Tears sampling