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

MEK Inhibitor-Associated Serous Retinopathy Clinical Trial

— CAPITOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222387
• Other study ID #: CSA_2019_13
• Status: Completed
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: June 19, 2023

Study information

• Verified date: June 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 19, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MEK Inhibitor-Associated Serous Retinopathy
• Retinal Diseases

Intervention

Device:
• OCT-B scan
OCT-B scan (Optical coherence tomography)

Locations

Country	Name	City	State
France	Fondation A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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