MEK Inhibitor-Associated Serous RetinopathyCAPITOXNCT04222387
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines
A study testing OCT-B scan in people with MEK Inhibitor-Associated Serous Retinopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MEK Inhibitor-Associated Serous Retinopathy
- What is being tested?
- OCT-B scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2019to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hair dye up to one month before the inclusion
- Hair dye product containing aromatic amines
Who cannot join
- Pregnant or lactating woman
- Retinal pathology already known, or central serous choroiditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- OCT-B scan
- Keywords
- MEK Inhibitor-Associated Serous Retinopathy, Hair dye, Aromatic amines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-B scanDevice
OCT-B scan (Optical coherence tomography)
| Study group | Role | What they receive |
|---|---|---|
| Participants with hair dye | Experimental | Hair dye product with pPD Type Aromatic Amines used up to 1 month before Receives: Device: OCT-B scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with MEKAR retinopathy detected on OCT-B scan
Physiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan
Measured: Day of inclusion, up to one month month after the last hair dye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start19 Dec 2019
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MEK Inhibitor-Associated Serous RetinopathyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Claire SCEMAMA, MD, Principal investigator, cstimsit@for.paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222387
- Sponsor's protocol ID
- CSA_2019_13
- Acronym
- CAPITOX
- Status last verified
- Jun 2023
- First submitted
- 11 Dec 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD (Para-phenylenediamine) Type Aromatic Amines
- ClinicalTrials.gov ID
- NCT04222387
- Acronym / sponsor ID
- CAPITOX / CSA_2019_13
- Keywords
- MEK Inhibitor-Associated Serous Retinopathy, Hair dye, Aromatic amines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with hair dye | Experimental | Device: OCT-B scanHair dye product with pPD Type Aromatic Amines used up to 1 month before |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hair dye up to one month before the inclusion
- Hair dye product containing aromatic amines
Key exclusion criteria (2 listed)
- Pregnant or lactating woman
- Retinal pathology already known, or central serous choroiditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT-B scanOCT-B scan (Optical coherence tomography) | Device | Participants with hair dye |
Primary outcome
% of patients with MEKAR retinopathy detected on OCT-B scan
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire SCEMAMA, MD principal investigator
cstimsit@for.paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT-B scan in people with MEK Inhibitor-Associated Serous Retinopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with MEKAR retinopathy detected on OCT-B scan (time frame: Day of inclusion, up to one month month after the last hair dye). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.