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Canthaxanthin Retinopathy: A Long-term Observation

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01128062
First received: May 20, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first described in 1982 by Cortin et al. In Germany the office of the federal board of health refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time the long-term course of the disease was not known. 25 years later the investigators did these long-term follow-up examinations.


Condition
Canthaxanthin Retinopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • all eye diseases [ Time Frame: 2008 and 2009 ] [ Designated as safety issue: No ]
    All patients will have the follow-up examination 2008 or 2009. The examination included at most visual acuity (distant and near vision), Amsler test, examination of anterior segment, posterior segment, 10-2 and 30-2 visual field, electrooculography, electroretinography, multifocal electroretinography, fundus photography, fluorescein angiography, and an examination for autofluorescence.


Enrollment: 35
Study Start Date: December 1983
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a history of oral tanning agents should report at the University Eye hospital for examination.

Criteria

Inclusion Criteria:

  • patients using oral tanning agents for at least 2 months.
  • patients of 18 years or older

Exclusion Criteria:

  • none.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128062

Locations
Germany
University Eye Hospital, University of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University of Cologne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01128062     History of Changes
Other Study ID Numbers: AHARMS-8310
Study First Received: May 20, 2010
Last Updated: May 20, 2010
Health Authority: Germany: Ministry of Health

Keywords provided by University of Cologne:
Canthaxanthin retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Eye Diseases
Canthaxanthin
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013