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

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

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.

Study Overview

• Status: Completed
• Conditions: MEK Inhibitor-Associated Serous Retinopathy
• Intervention / Treatment: Device: OCT-B scan

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martine MAUGET FAYSSE, MD; Phone Number: +33 (0)148036440; Email: mmfaysse@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Fondation A De Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with hair dye; Hair dye product with pPD Type Aromatic Amines used up to 1 month before	Device: OCT-B scan; OCT-B scan (Optical coherence tomography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with MEKAR retinopathy detected on OCT-B scan	Physiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan	Day of inclusion, up to one month month after the last hair dye

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Claire SCEMAMA, MD, cstimsit@for.paris

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): June 19, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Aromatic amines; MEK Inhibitor-Associated Serous Retinopathy; Hair dye
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: CSA_2019_13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No