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Trial record 3 of 27 for:    papilledema

Antiacne Medications Pseudotumor Cerebri (AAMPTC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02149615
Recruitment Status : Unknown
Verified May 2014 by University of Zurich.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE April 7, 2014
First Posted Date  ICMJE May 29, 2014
Last Update Posted Date May 29, 2014
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiacne Medications Pseudotumor Cerebri
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Optic Disc Swelling
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: isotretinoin
    Retinal nerve fibre layer measurement in patients under isotretinoin treatment
    Intervention: Other: Retinal nerve fibre layer measurement
  • Active Comparator: lymecycline
    Retinal nerve fibre layer measurement in patients under lymecycline treatment
    Intervention: Other: Retinal nerve fibre layer measurement
  • Active Comparator: minocycline
    Retinal nerve fibre layer measurement in patients under minocycline treatment
    Intervention: Other: Retinal nerve fibre layer measurement
  • Active Comparator: doxycycline
    Retinal nerve fibre layer measurement in patients under doxycycline treatment
    Intervention: Other: Retinal nerve fibre layer measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2014)
310
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

- age < 18 years

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02149615
Other Study ID Numbers  ICMJE KEK-ZH 2013-0433 AAMPTC
2013DR4066 ( Other Identifier: Swiss Medic )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE University Hospital, Zürich
Investigators  ICMJE
Study Chair: Klara Landau, Prof MD UniversityHospital, Zurich
PRS Account University of Zurich
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP