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Trial record 9 of 31 for:    Pseudotumor Cerebri

Antiacne Medications Pseudotumor Cerebri (AAMPTC)

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ClinicalTrials.gov Identifier: NCT02149615
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Collaborator:
University Hospital, Zürich
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.

Condition or disease Intervention/treatment Phase
Optic Disc Swelling Other: Retinal nerve fibre layer measurement Phase 4

Detailed Description:
Measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Open-label Phase IV Trial to Investigate the Frequency of Optic Disc Swelling, Idiopathic Intracranial Hypertension and Dry Eye Symptoms Under Antiacne Medication Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: isotretinoin
Retinal nerve fibre layer measurement in patients under isotretinoin treatment
Other: Retinal nerve fibre layer measurement
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Name: effect of medication on optic nerve fibre layer

Active Comparator: lymecycline
Retinal nerve fibre layer measurement in patients under lymecycline treatment
Other: Retinal nerve fibre layer measurement
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Name: effect of medication on optic nerve fibre layer

Active Comparator: minocycline
Retinal nerve fibre layer measurement in patients under minocycline treatment
Other: Retinal nerve fibre layer measurement
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Name: effect of medication on optic nerve fibre layer

Active Comparator: doxycycline
Retinal nerve fibre layer measurement in patients under doxycycline treatment
Other: Retinal nerve fibre layer measurement
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Name: effect of medication on optic nerve fibre layer




Primary Outcome Measures :
  1. Retinal nerve fibre layer [ Time Frame: 9 months ]

    Measurement of retinal nerve fibre layer using optical coherence tomography. Changes over 10 micrometers are considered to be clinically relevant.

    The Term "retinal nerve fibre layer" describes an automated standardized optical coherence tomography measurement program measuring the sectorial thickness of the peripapillar retinal nerve fibre layer. There exists no other term for that.




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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:

  • Antiacne medication treatment indicated by dermatologist
  • age > 18 years
  • contraception if indicated

Exclusion Criteria:

- age < 18 years


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): NCT02149615


Contacts
Contact: Gregor Jaggi, MD 0041 44 255 49 00 gregor.jaggi@usz.ch
Contact: Isabelle Meneau isabelle@meneau@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Isabelle Meneau       isabelle.meneau@usz.ch   
Principal Investigator: Gregor Jaggi, MD         
Sponsors and Collaborators
University of Zurich
University Hospital, Zürich
Investigators
Study Chair: Klara Landau, Prof MD UniversityHospital, Zurich

Additional Information:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02149615     History of Changes
Other Study ID Numbers: KEK-ZH 2013-0433 AAMPTC
2013DR4066 ( Other Identifier: Swiss Medic )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by University of Zurich:
idiopathic intracranial hypertension
optic disc swelling
antiacne medication
isotretinoin

Additional relevant MeSH terms:
Pseudotumor Cerebri
Intracranial Hypertension
Papilledema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Isotretinoin
Lymecycline
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents