Acne VulgarisPhase 4NCT01404130
A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
A Phase 4 study testing Isotretinoin in people with Acne Vulgaris, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Isotretinoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult subjects age 16 and over with acne vulgaris
- 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
Who cannot join
- Subjects already on treatment with isotretinoin
- Subjects with below normal intelligence who would not understand the CANTAB psychological tests
- Subjects with neurological disease e.g. epilepsy or pre-existing mental health problems
- Pregnant females or females not taking preventive precautions
- Subjects on sedative or psycho-active medications that could interfere with the outcomes tested
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
- Generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group
- Test of CANTAB, questionnaires and data collection forms
- Select most appropriate outcome measures
- Identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies It was not considered to randomise subjects to placebo.
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin
- Keywords
- isotretinoin, hippocampus, memory, learning, CANTAB
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called Accutane, Roaccutane, 13-cid retinoic acid
0.5-1mg/kg daily for 4-6 months
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin therapy | Experimental | 0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive change measured by delayed matching to sample (CANTAB)
Measured: 3 months on treatment
Secondary outcomes (4)
Change in spacial recognition memory (CANTAB)
Measured: 0, 3 months and one month after stopping
Change in Paired Associate learning (CANTAB)
Measured: 0, 3 months and one month after stopping
Change in Spacial recognition memory
Measured: 0, 3months and one month after stopping
Cambridge gambling task - changes
Measured: 0, 3months and one month after stopping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Investigators
- Anthony Ormerod, MB MD FRCP, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404130
- Sponsor's protocol ID
- 07/S0802/135
- Status last verified
- Jul 2011
- First submitted
- 19 Jul 2011
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
- ClinicalTrials.gov ID
- NCT01404130
- Acronym / sponsor ID
- 07/S0802/135
- Conditions
- Acne Vulgaris
- Keywords
- isotretinoin, hippocampus, memory, learning, CANTAB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group
- Test of CANTAB, questionnaires and data collection forms
- Select most appropriate outcome measures
- Identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies It was not considered to randomise subjects to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin therapy | Experimental | Drug: Isotretinoin0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult subjects age 16 and over with acne vulgaris
- 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
Key exclusion criteria (5 listed)
- Subjects already on treatment with isotretinoin
- Subjects with below normal intelligence who would not understand the CANTAB psychological tests
- Subjects with neurological disease e.g. epilepsy or pre-existing mental health problems
- Pregnant females or females not taking preventive precautions
- Subjects on sedative or psycho-active medications that could interfere with the outcomes tested
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsotretinoinAlso: Accutane, Roaccutane, 13-cid retinoic acid0.5-1mg/kg daily for 4-6 months | Drug | Isotretinoin therapy |
Primary outcome
Cognitive change measured by delayed matching to sample (CANTAB)
Time frame: 3 months on treatment
4 secondary outcomes
Change in spacial recognition memory (CANTAB)
Time frame: 0, 3 months and one month after stopping
Change in Paired Associate learning (CANTAB)
Time frame: 0, 3 months and one month after stopping
Change in Spacial recognition memory
Time frame: 0, 3months and one month after stopping
Cambridge gambling task - changes
Time frame: 0, 3months and one month after stopping
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Ormerod, MB MD FRCP principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isotretinoin in people with Acne Vulgaris, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive change measured by delayed matching to sample (CANTAB) (time frame: 3 months on treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2011.