Acne Vulgaris
Conditions
Keywords
isotretinoin, hippocampus, memory, learning, CANTAB
Brief summary
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.
Interventions
DRUGIsotretinoin
0.5-1mg/kg daily for 4-6 months
Sponsors
University of Aberdeen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult subjects age 16 and over with acne vulgaris 2. Cases should be candidates for isotretinoin therapy should have severe acne not responding to treatment and at risk of scarring and have discussed the risks, pregnancy prevention program and benefits of this treatment according to normal clinical practise
Exclusion criteria
1. Subjects already on treatment with isotretinoin 2. Subjects with below normal intelligence who would not understand the CANTAB psychological tests 3. Subjects with neurological disease e.g. epilepsy or pre-existing mental health problems 4. Pregnant females or females not taking preventive precautions 5. Subjects on sedative or psycho-active medications that could interfere with the outcomes tested
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive change measured by delayed matching to sample (CANTAB) | 3 months on treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in spacial recognition memory (CANTAB) | 0, 3 months and one month after stopping |
| Change in Paired Associate learning (CANTAB) | 0, 3 months and one month after stopping |
| Change in Spacial recognition memory | 0, 3months and one month after stopping |
| Cambridge gambling task - changes | 0, 3months and one month after stopping |
Countries
United Kingdom
Outcome results
None listed