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

NCT ID: NCT04222387

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2023-06-19

Brief Summary

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.

Conditions

MEK Inhibitor-Associated Serous Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Participants with hair dye

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

Group Type: EXPERIMENTAL

OCT-B scan

Intervention Type: DEVICE

OCT-B scan (Optical coherence tomography)

Interventions

OCT-B scan

OCT-B scan (Optical coherence tomography)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire SCEMAMA, MD

Role: PRINCIPAL_INVESTIGATOR

cstimsit@for.paris

Locations

Fondation A de Rothschild

Paris, , France

Countries

France

Other Identifiers

CSA_2019_13

Identifier Type: -

Identifier Source: org_study_id