Cutaneous Lupus Medication Experience Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02176148|
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment|
|Cutaneous Lupus||Drug: fluocinonide 0.05% cream|
Cutaneous lupus is a chronic, relapsing auto-immune disease that negatively impacts patients' quality of life. As there are many safe topical therapies that require daily use to be effective, and adherence to medication remains a common problem in dermatology, it is worthwhile to reliably measure adherence to medication in patients with cutaneous lupus. By elucidating barriers to effective control of cutaneous lupus with topical medications, we can improve patient care and guide interventions that will avoid the use of systemic therapy which often has more side effects.
The primary aim is to determine adherence to topical and systemic lupus treatment. Subjects will receive standard of care therapy (low potency and high potency topical corticosteroids) and systemic therapy when clinically appropriate. Adherence to medications will be monitored electronically in all subjects. The following hypothesis is to be tested: Non-adherence to topical and systemic medication contributes to treatment failure in patients with cutaneous lupus.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Cutaneous Lupus Medication Experience Study|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2019|
Lupus control standard-of-care
Each person enrolled will be given fluocinonide 0.05% cream to apply twice daily to active areas.
Drug: fluocinonide 0.05% cream
- Change in Adherence Measures [ Time Frame: up to 6 month ]There will be interim measures taken after the baseline measure at month 1, month 3, and at end point month 6.
- Disease Severity Measures [ Time Frame: 6 months ]
Assessments will be taken at baseline, month 1, month 3, and at end point month 6.
- Change in cutaneous lupus severity, measured by the Investigator's Global Assessment of severity (IGA) and Cutaneous Lupus Erythematosus Disease Area Severity Index (CLASI) scales.
- Factors that affect adherence to lupus treatment, including physician trust, trust in the medication, and confidence in the treatment plan which will be measured with the Wake Forest University Physician Trust Scale (WFUPTS). and the Treatment Satisfaction Questionnaire for Medication (TSQM).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176148
|Contact: Irma M Richardson, MHAfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University School of Medicine - Department of Dermatology||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Adele Clark, PA-C 336-716-3775 email@example.com|
|Principal Investigator: William W Huang, MD,MPH,FAAD|
|Principal Investigator:||William W Huang, MD, MPH, FAAD||Wake Forest University Health Sciences|