Acne Vulgaris Clinical Trial
Official title:
A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
This prospective study tested the effects of isotretinoin in a cohort of patients receiving
standard therapy for acne vulgaris. Subjects completed questionnaires and standardised
computer based cognitive testing using CANTAB to test for cognitive effects particularly on
learning and memory. Test were conducted before starting isotretinoin, after 3 months and
again a month after finishing therapy. This was carried out as a pilot study to
1. Test the hypothesis that oral isotretinoin, over its 4-month treatment time, will
result in a decline in learning and memory as measured using the CANTAB series of test.
2. Generate data for sample size calculation for a larger study to determine the changes
in memory over time in drug and control group
3. Test of CANTAB, questionnaires and data collection forms
4. Select most appropriate outcome measures
5. Identify therapy sensitive cognitive tasks which would be used in future functional
brain imaging studies It was not considered to randomise subjects to placebo.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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