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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT04222387

Collaborator

(none)

100

Enrollment

Location

Arm

41.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
MEK Inhibitor-Associated Serous Retinopathy	Device: OCT-B scan	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 19, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation A de Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: Claire SCEMAMA, MD, cstimsit@for.paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04222387

Other Study ID Numbers:

CSA_2019_13

First Posted:

Jan 10, 2020

Last Update Posted:

Jan 25, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild

MEK Inhibitor-Associated Serous Retinopathy

Hair dye

Aromatic amines

Additional relevant MeSH terms:

Retinal Diseases

Study Results

No Results Posted as of Jan 25, 2022