Antiacne Medications Pseudotumor Cerebri (AAMPTC)

May 26, 2014 updated by: University of Zurich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

310

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • effect of medication on optic nerve fibre layer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Zürich

Investigators

  • Study Chair: Klara Landau, Prof MD, UniversityHospital, Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

May 26, 2014

First Posted (ESTIMATE)

May 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH 2013-0433 AAMPTC
  • 2013DR4066 (OTHER: Swiss Medic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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