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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04222387
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.

Condition or disease Intervention/treatment Phase
MEK Inhibitor-Associated Serous Retinopathy Device: OCT-B scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD (Para-phenylenediamine) Type Aromatic Amines
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants with hair dye
Hair dye product with pPD Type Aromatic Amines used up to 1 month before
Device: OCT-B scan
OCT-B scan (Optical coherence tomography)




Primary Outcome Measures :
  1. % 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222387


Contacts
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Contact: Amélie YAVCHITZ, MD (0)148036454 ext +33 ayavchitz@for.paris
Contact: Martine MAUGET FAYSSE, MD (0)148036440 ext +33 mmfaysse@for.paris

Locations
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France
Fondation A de Rothschild Recruiting
Paris, France, 75019
Contact: Claire SCEMAMA, MD       ctimsit@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Claire SCEMAMA, MD cstimsit@for.paris

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04222387    
Other Study ID Numbers: CSA_2019_13
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
MEK Inhibitor-Associated Serous Retinopathy
Hair dye
Aromatic amines
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases