Cutaneous Lupus ErythematosusNCT01629784
Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus
A study testing Cutaneous Lupus educational script in people with Cutaneous Lupus Erythematosus, run by Northwestern University at 1 site in United States.
Trial summary
Studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with Caucasians. There are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lupus Erythematosus
- What is being tested?
- Cutaneous Lupus educational script
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2013
- 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 with a diagnosis of cutaneous lupus erythematous
- Subjects ages 18 years of age and older and able to give consent
Who cannot join
- That which does not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with Caucasians. There are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators hypothesize that there are disparities in knowledge about photoprotection, leading to poorer outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and triggers, especially sun exposure, and the effects on quality of life of Caucasian and minority populations, by conducting an assessment survey and subsequent teaching intervention on appropriate skin protection techniques including appropriate sun screen application, and use of sun-protective clothing. After three months a survey to evaluate knowledge retention about and the application of the educational intervention will be conducted.
- Conditions
- Cutaneous Lupus Erythematosus
- Being tested
- Cutaneous Lupus educational script
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous Lupus educational scriptBehavioural
Subjects will listen to a short informational script on Cutaneous lupus and skin protection
| Study group | Role | What they receive |
|---|---|---|
| CLE and sun counseling | Other | Not described Receives: Behavioral: Cutaneous Lupus educational script |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture
In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.
Measured: immediately before and after an educational lecture
Secondary outcomes (1)
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture
In order to evaluate the long-term effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a questionnaire to assess knowledge about CLE and sun protection behaviors immediately before and three months after an educational lecture. The percentage of subjects who correctly answered a knowledge or behavioral assessment item were calculated pre- and three months post-educational lecture.
Measured: before and 3 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 completionJan 2013
- Study completionJan 2013
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 (4)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Lupus ErythematosusStudies 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
- 31 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, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629784
- Sponsor's protocol ID
- STU65095
- Status last verified
- Apr 2013
- First submitted
- 26 Jun 2012
- Last updated
- 3 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg. 1998 Dec;17(4):291-6. doi: 10.1016/s1085-5629(98)80026-6.
PubMed 9859917Foering K, Goreshi R, Klein R, Okawa J, Rose M, Cucchiara A, Werth VP. Prevalence of self-report photosensitivity in cutaneous lupus erythematosus. J Am Acad Dermatol. 2012 Feb;66(2):220-8. doi: 10.1016/j.jaad.2010.12.006. Epub 2011 Jul 13.
PubMed 21742409Kundu RV, Kamaria M, Ortiz S, West DP, Rademaker AW, Robinson JK. Effectiveness of a knowledge-based intervention for melanoma among those with ethnic skin. J Am Acad Dermatol. 2010 May;62(5):777-84. doi: 10.1016/j.jaad.2009.08.047. Epub 2010 Mar 9.
PubMed 20219266Werth VP. Clinical manifestations of cutaneous lupus erythematosus. Autoimmun Rev. 2005 Jun;4(5):296-302. doi: 10.1016/j.autrev.2005.01.003. Epub 2005 Feb 10.
PubMed 15990077
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01629784
- Acronym / sponsor ID
- STU65095
- Conditions
- Cutaneous Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Posted 3 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with Caucasians. There are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. Cutaneous Lupus Erythematosus (CLE) is a disease of flares and remissions with identifiable triggers. One of the most aggravating triggers in CLE is sun exposure. The investigators hypothesize that there are disparities in knowledge about photoprotection, leading to poorer outcomes in minority ethnic groups. This study aims to assess knowledge of risk factors and triggers, especially sun exposure, and the effects on quality of life of Caucasian and minority populations, by conducting an assessment survey and subsequent teaching intervention on appropriate skin protection techniques including appropriate sun screen application, and use of sun-protective clothing. After three months a survey to evaluate knowledge retention about and the application of the educational intervention will be conducted.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLE and sun counseling | Other | Behavioral: Cutaneous Lupus educational script |
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 with a diagnosis of cutaneous lupus erythematous
- Subjects ages 18 years of age and older and able to give consent
Key exclusion criteria (1 listed)
- That which does not fit the inclusion criteria
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 |
|---|---|---|
| Cutaneous Lupus educational scriptSubjects will listen to a short informational script on Cutaneous lupus and skin protection | Behavioural | CLE and sun counseling |
Primary outcome
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture
Time frame: immediately before and after an educational lecture
In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.
1 secondary outcome
Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture
Time frame: before and 3 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 3 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9859917Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg. 1998 Dec;17(4):291-6. doi: 10.1016/s1085-5629(98)80026-6.
- Background: PubMed 21742409Foering K, Goreshi R, Klein R, Okawa J, Rose M, Cucchiara A, Werth VP. Prevalence of self-report photosensitivity in cutaneous lupus erythematosus. J Am Acad Dermatol. 2012 Feb;66(2):220-8. doi: 10.1016/j.jaad.2010.12.006. Epub 2011 Jul 13.
- Background: PubMed 20219266Kundu RV, Kamaria M, Ortiz S, West DP, Rademaker AW, Robinson JK. Effectiveness of a knowledge-based intervention for melanoma among those with ethnic skin. J Am Acad Dermatol. 2010 May;62(5):777-84. doi: 10.1016/j.jaad.2009.08.047. Epub 2010 Mar 9.
- Background: PubMed 15990077Werth VP. Clinical manifestations of cutaneous lupus erythematosus. Autoimmun Rev. 2005 Jun;4(5):296-302. doi: 10.1016/j.autrev.2005.01.003. Epub 2005 Feb 10.
- Northwestern University Department of Dermatology Actively Enrolling Research TrialsLink provided by the sponsor.
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A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
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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.
Roopal Kundu, M.D. 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 Cutaneous Lupus educational script in people with Cutaneous Lupus Erythematosus, 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 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 3 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 3 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?
Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an 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 NCT01629784, which also lists 4 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 3 Jun 2013; AzTrials last refreshed its copy on 30 Oct 2026.