ClinicalTrials.gg
CompletedNCT04222387CAPITOXUpdated Jun 22, 2023

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

An interventional study of OCT-B scan in MEK Inhibitor-Associated Serous Retinopathy, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • MEK Inhibitor-Associated Serous Retinopathy

Keywords

  • MEK Inhibitor-Associated Serous Retinopathy
  • Hair dye
  • Aromatic amines
03

In context

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 315 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hair dye up to one month before the inclusion
  • Hair dye product containing aromatic amines

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating woman
  • Retinal pathology already known, or central serous choroiditis
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Participants with hair dye

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

    Device: OCT-B scan

Interventions

  • DeviceOCT-B scan

    OCT-B scan (Optical coherence tomography)

06

What researchers measure

Primary outcomes

  1. % of patients with MEKAR retinopathy detected on OCT-B scan

    Physiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan

    Time frame: Day of inclusion, up to one month month after the last hair dye

07

Study locations

1 site
  • Fondation A de Rothschild
    Paris, 75019, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2019 to primary completion in Jun 2023, 42 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2019
First posted
Jan 10, 2020
StartActual
Dec 19, 2019
Primary completionActual
Jun 19, 2023
CompletionActual
Jun 19, 2023
Last update
Jun 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04222387
Responsible party
Sponsor
First posted
Jan 10, 2020
Start date
Dec 19, 2019
Primary completion
Jun 19, 2023
Completion
Jun 19, 2023
Last update
Jun 22, 2023

Study contacts

Claire SCEMAMA, MD
principal investigator · cstimsit@for.paris

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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