- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149615
Antiacne Medications Pseudotumor Cerebri (AAMPTC)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Isabelle Meneau
- Email: isabelle@meneau@usz.ch
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich
-
Contact:
- Isabelle Meneau
- Email: isabelle.meneau@usz.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Antiacne medication treatment indicated by dermatologist
- age > 18 years
- contraception if indicated
Exclusion Criteria:
- age < 18 years
Study Plan
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
|
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Names:
|
ACTIVE_COMPARATOR: lymecycline
Retinal nerve fibre layer measurement in patients under lymecycline treatment
|
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Names:
|
ACTIVE_COMPARATOR: minocycline
Retinal nerve fibre layer measurement in patients under minocycline treatment
|
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Names:
|
ACTIVE_COMPARATOR: doxycycline
Retinal nerve fibre layer measurement in patients under doxycycline treatment
|
Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Study Chair: Klara Landau, Prof MD, UniversityHospital, Zurich
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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