Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines (CAPITOX)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: MEK Inhibitor-Associated Serous Retinopathy

Treatments: Device: OCT-B scan

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04222387

CSA_2019_13

Details and patient eligibility

About

Hair dye products could induce minimal forms of MEKAR retinopathies (Mitogen-activated Extracellular signal-regulated Kinase - inhibitors associated retinopathies). These minimal forms of MEKAR are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. The aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by MEKAR retinopathies can be induced.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hair dye up to one month before the inclusion
• Hair dye product containing aromatic amines

Exclusion criteria

• Pregnant or lactating woman
• Retinal pathology already known, or central serous choroiditis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Participants with hair dye

Experimental group

Description:

Hair dye product with pPD Type Aromatic Amines used up to 1 month before

Treatment:

Device: OCT-B scan