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Antiacne Medications Pseudotumor Cerebri (AAMPTC)

Primary Purpose

Optic Disc Swelling

Status

Unknown status

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Retinal nerve fibre layer measurement

About this trial

This is an interventional treatment trial for Optic Disc Swelling focused on measuring idiopathic intracranial hypertension, optic disc swelling, antiacne medication, isotretinoin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- age < 18 years

Sites / Locations

University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

isotretinoin

lymecycline

minocycline

doxycycline

Arm Description

Retinal nerve fibre layer measurement in patients under isotretinoin treatment

Retinal nerve fibre layer measurement in patients under lymecycline treatment

Retinal nerve fibre layer measurement in patients under minocycline treatment

Retinal nerve fibre layer measurement in patients under doxycycline treatment

Outcomes

Primary Outcome Measures

Retinal nerve fibre layer

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02149615

First Posted

April 7, 2014

Last Updated

May 26, 2014

Sponsor

University of Zurich

Collaborators

University Hospital, Zürich

1. Study Identification

Unique Protocol Identification Number

NCT02149615

Brief Title

Antiacne Medications Pseudotumor Cerebri

Acronym

AAMPTC

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 Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

University Hospital, Zürich

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Optic Disc Swelling

Keywords

idiopathic intracranial hypertension, optic disc swelling, antiacne medication, isotretinoin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

isotretinoin

Arm Type

Experimental

Arm Description

Retinal nerve fibre layer measurement in patients under isotretinoin treatment

Arm Title

lymecycline

Arm Type

Active Comparator

Arm Description

Retinal nerve fibre layer measurement in patients under lymecycline treatment

Arm Title

minocycline

Arm Type

Active Comparator

Arm Description

Retinal nerve fibre layer measurement in patients under minocycline treatment

Arm Title

doxycycline

Arm Type

Active Comparator

Arm Description

Retinal nerve fibre layer measurement in patients under doxycycline treatment

Intervention Type

Other

Intervention Name(s)

Retinal nerve fibre layer measurement

Other Intervention Name(s)

effect of medication on optic nerve fibre layer

Intervention Description

Measurement of retinal nerve fibre layer thickness using optic coherence tomography.

Primary Outcome Measure Information:

Title

Retinal nerve fibre layer

Description

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Antiacne medication treatment indicated by dermatologist age > 18 years contraception if indicated Exclusion Criteria: - age < 18 years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gregor Jaggi, MD

Phone

0041 44 255 49 00

gregor.jaggi@usz.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Isabelle Meneau

isabelle@meneau@usz.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klara Landau, Prof MD

Organizational Affiliation

UniversityHospital, Zurich

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital Zurich

City

Zurich

State/Province

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle Meneau

isabelle.meneau@usz.ch

First Name & Middle Initial & Last Name & Degree

Gregor Jaggi, MD

12. IPD Sharing Statement

Links:

URL

http://www.kofam.ch

Description

Study register Switzerland

Learn more about this trial

Antiacne Medications Pseudotumor Cerebri

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