Back to resultsInvestigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines (CAPITOX)
Primary Purpose
MEK Inhibitor-Associated Serous Retinopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OCT-B scan
Sponsored by
About this trial
This is an interventional diagnostic trial for MEK Inhibitor-Associated Serous Retinopathy focused on measuring MEK Inhibitor-Associated Serous Retinopathy, Hair dye, Aromatic amines
Eligibility Criteria
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
Sites / Locations
- Fondation A de Rothschild
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with hair dye
Arm Description
Hair dye product with pPD Type Aromatic Amines used up to 1 month before
Outcomes
Primary Outcome Measures
% of patients with MEKAR retinopathy detected on OCT-B scan
Physiological parameter : Serous retinal detachment at the posterior pole, detected on OCT-B scan
Secondary Outcome Measures
Full Information
NCT ID
NCT04222387
First Posted
December 11, 2019
Last Updated
June 19, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT04222387
Brief Title
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines
Acronym
CAPITOX
Official Title
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD (Para-phenylenediamine) Type Aromatic Amines
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MEK Inhibitor-Associated Serous Retinopathy
Keywords
MEK Inhibitor-Associated Serous Retinopathy, Hair dye, Aromatic amines
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with hair dye
Arm Type
Experimental
Arm Description
Hair dye product with pPD Type Aromatic Amines used up to 1 month before
Intervention Type
Device
Intervention Name(s)
OCT-B scan
Intervention Description
OCT-B scan (Optical coherence tomography)
Primary Outcome Measure Information:
Title
% of patients with MEKAR retinopathy detected on OCT-B scan
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire SCEMAMA, MD
Organizational Affiliation
cstimsit@for.paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines
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