Acne VulgarisNCT01629797
Knowledge Evaluation and Assessment of the Effectiveness of an Education Intervention on Acne
A study testing Educational script on Acne in people with Acne Vulgaris, run by Northwestern University at 1 site in United States.
Trial summary
Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of the hair follicle, associated with oil production. It is found across skin types and is present in 85% of adolescents, representing a large affected population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Educational script on Acne
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ages 18 years of age and older and able to give consent
- Subjects with a diagnosis of acne vulgaris
Who cannot join
- Subjects who are not proficient in English
- Subjects who were unable to give informed consent
- Subjects who do not have a diagnosis of acne vulgaris
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of the hair follicle, associated with oil production. It is found across skin types and is present in 85% of adolescents, representing a large affected population. Because of the universal nature of the disease, 36.3% of acne patients come from backgrounds other than Caucasian.
The purpose of this study is to examine patient knowledge about acne in different populations and to assess the effectiveness of a teaching intervention on acne knowledge. The investigators aim is to better understand and subsequently reduce any potential health disparities within the minority populations.
This project will evaluate differences in acne knowledge between different ethnic groups, and the efficacy of an educational intervention. Subjects will first complete a survey evaluating their knowledge of acne and how acne affects them psychosocially before an educational intervention. Immediately following the intervention, the patient's knowledge of acne will be evaluated again. Finally, two months after the intervention, a phone call will be made evaluating their retention of the education materials and their quality of life related to psychosocial effects of acne. Investigating this educational intervention and any current disparities in acne education and understanding will better allow us to educate and treat acne patients in the future.
- Conditions
- Acne Vulgaris
- Being tested
- Educational script on Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational script on AcneBehavioural
An educational script on Acne will be presented by investigator
| Study group | Role | What they receive |
|---|---|---|
| Acne Vulgaris | Other | Patients with Acne vulgaris will receive educational teaching on Acne Receives: Behavioral: Educational script on Acne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture
In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture.
Measured: immediately before and after an educational lecture
Secondary outcomes (1)
Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture
In order to evaluate the long-term effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and two months after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and two months post-educational lecture.
Measured: before and 2 months after an educational lecture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roopal Kundu, Northwestern University
- Investigators
- Roopal Kundu, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629797
- Sponsor's protocol ID
- STU64905
- Status last verified
- Apr 2013
- First submitted
- 26 Jun 2012
- Last updated
- 20 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Callender VD. Acne in ethnic skin: special considerations for therapy. Dermatol Ther. 2004;17(2):184-95. doi: 10.1111/j.1396-0296.2004.04019.x.
PubMed 15113286Cheng CE, Irwin B, Mauriello D, Liang L, Pappert A, Kimball AB. Self-reported acne severity, treatment, and belief patterns across multiple racial and ethnic groups in adolescent students. Pediatr Dermatol. 2010 Sep-Oct;27(5):446-52. doi: 10.1111/j.1525-1470.2010.01286.x. Epub 2010 Aug 26.
PubMed 20796234Dreno B. Assessing quality of life in patients with acne vulgaris: implications for treatment. Am J Clin Dermatol. 2006;7(2):99-106. doi: 10.2165/00128071-200607020-00003.
PubMed 16605290Hanna S, Sharma J, Klotz J. Acne vulgaris: more than skin deep. Dermatol Online J. 2003 Aug;9(3):8.
PubMed 12952755Tan JK, Vasey K, Fung KY. Beliefs and perceptions of patients with acne. J Am Acad Dermatol. 2001 Mar;44(3):439-45. doi: 10.1067/mjd.2001.111340.
PubMed 11209112Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.
PubMed 21880356
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Evaluation and Assessment of the Effectiveness of an Education Intervention on Acne
- ClinicalTrials.gov ID
- NCT01629797
- Acronym / sponsor ID
- STU64905
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Posted 20 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is a chronic inflammatory disorder of the skin in the pilosebaceous unit of the hair follicle, associated with oil production. It is found across skin types and is present in 85% of adolescents, representing a large affected population. Because of the universal nature of the disease, 36.3% of acne patients come from backgrounds other than Caucasian.
The purpose of this study is to examine patient knowledge about acne in different populations and to assess the effectiveness of a teaching intervention on acne knowledge. The investigators aim is to better understand and subsequently reduce any potential health disparities within the minority populations.
This project will evaluate differences in acne knowledge between different ethnic groups, and the efficacy of an educational intervention. Subjects will first complete a survey evaluating their knowledge of acne and how acne affects them psychosocially before an educational intervention. Immediately following the intervention, the patient's knowledge of acne will be evaluated again. Finally, two months after the intervention, a phone call will be made evaluating their retention of the education materials and their quality of life related to psychosocial effects of acne. Investigating this educational intervention and any current disparities in acne education and understanding will better allow us to educate and treat acne patients in the future.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne Vulgaris | Other | Behavioral: Educational script on AcnePatients with Acne vulgaris will receive educational teaching on Acne |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects ages 18 years of age and older and able to give consent
- Subjects with a diagnosis of acne vulgaris
Key exclusion criteria (3 listed)
- Subjects who are not proficient in English
- Subjects who were unable to give informed consent
- Subjects who do not have a diagnosis of acne vulgaris
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 |
|---|---|---|
| Educational script on AcneAn educational script on Acne will be presented by investigator | Behavioural | Acne Vulgaris |
Primary outcome
Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture
Time frame: immediately before and after an educational lecture
In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture.
1 secondary outcome
Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture
Time frame: before and 2 months after an educational lecture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15113286Callender VD. Acne in ethnic skin: special considerations for therapy. Dermatol Ther. 2004;17(2):184-95. doi: 10.1111/j.1396-0296.2004.04019.x.
- Background: PubMed 20796234Cheng CE, Irwin B, Mauriello D, Liang L, Pappert A, Kimball AB. Self-reported acne severity, treatment, and belief patterns across multiple racial and ethnic groups in adolescent students. Pediatr Dermatol. 2010 Sep-Oct;27(5):446-52. doi: 10.1111/j.1525-1470.2010.01286.x. Epub 2010 Aug 26.
- Background: PubMed 16605290Dreno B. Assessing quality of life in patients with acne vulgaris: implications for treatment. Am J Clin Dermatol. 2006;7(2):99-106. doi: 10.2165/00128071-200607020-00003.
- Background: PubMed 12952755Hanna S, Sharma J, Klotz J. Acne vulgaris: more than skin deep. Dermatol Online J. 2003 Aug;9(3):8.
- Background: PubMed 11209112Tan JK, Vasey K, Fung KY. Beliefs and perceptions of patients with acne. J Am Acad Dermatol. 2001 Mar;44(3):439-45. doi: 10.1067/mjd.2001.111340.
- Background: PubMed 21880356Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.
- Northwestern University Department of Dermatology Actively Enrolling Research TrialsLink provided by the sponsor.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Roopal Kundu, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational script on Acne in people with Acne Vulgaris, run by Northwestern University at 1 site in United States.
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 3 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 20 Jun 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture (time frame: immediately before and after an educational lecture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629797, which also lists 6 linked publications.
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 20 Jun 2013.