Acne VulgarisNCT01931774
Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris
An observational study of Acne Vulgaris, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2013to Jul 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acne patients referred to the dermatology outpatient clinic of our university and healthy controls matched with the patient group for age, gender and years of education. Controls will be taken from the general population
Who may be able to join
- -
Who cannot join
- The participants that had a symptom or a history of mental retardation (IQ < 70), serious head trauma, seizures or any other mental disorder, and participants on any medical treatment will be excluded. Participants with a family history (first degree relatives) of schizophrenia, bipolar disorder or schizoaffective disorder will also be excluded to avoid the negative effect of these disorders on cognitive functions. The same exclusion criteria will also be applied to the control group.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Hospital
Istanbul, 34093
About this study
Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne.
The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris cognitive functions
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acne Patients | Not described | |
| Control Subjects | From General Population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functions
Measured: baseline
Secondary outcomes (1)
anxiety
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionJul 2013
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.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdem Deveci, Bezmialem Vakif University
- Investigators
- Erdem Deveci, Ass.Prof., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931774
- Sponsor's protocol ID
- Etik Kurul Karar No:36/14
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01931774
- Acronym / sponsor ID
- Etik Kurul Karar No:36/14
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris cognitive functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Aug 2013 (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.
Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne.
The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne Patients | – | – |
| Control Subjects | – | –From General Population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acne patients referred to the dermatology outpatient clinic of our university and healthy controls matched with the patient group for age, gender and years of education. Controls will be taken from the general population
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- The participants that had a symptom or a history of mental retardation (IQ < 70), serious head trauma, seizures or any other mental disorder, and participants on any medical treatment will be excluded. Participants with a family history (first degree relatives) of schizophrenia, bipolar disorder or schizoaffective disorder will also be excluded to avoid the negative effect of these disorders on cognitive functions. The same exclusion criteria will also be applied to the control group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive functions
Time frame: baseline
1 secondary outcome
anxiety
Time frame: baseline
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 29 Aug 2013.
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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.
Erdem Deveci, Ass.Prof. principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 29 Aug 2013. 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 Turkey (Türkiye). 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.
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 functions (time frame: baseline). 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 29 Aug 2013.