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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04222387
Acronym
CAPITOX
Enrollment
62
Registered
2020-01-10
Start date
2019-12-19
Completion date
2023-06-19
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MEK Inhibitor-Associated Serous Retinopathy

Keywords

MEK Inhibitor-Associated Serous Retinopathy, Hair dye, Aromatic amines

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.

Interventions

DEVICEOCT-B scan

OCT-B scan (Optical coherence tomography)

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
% of patients with MEKAR retinopathy detected on OCT-B scanDay of inclusion, up to one month month after the last hair dyePhysiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026