Cutaneous Lupus Medication Experience Study

Study Overview
=================
Brief Summary
-----------------
Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.

Detailed Description
-----------------
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.

Official Title
-----------------
Cutaneous Lupus Medication Experience Study

Conditions
-----------------
Cutaneous Lupus

Intervention / Treatment
-----------------
* Drug: fluocinonide 0.05% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any male or female 12 years or older of age with a diagnosis of cutaneous lupus by a dermatologist Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed Able to complete the study and comply with study instructions, including attending all study visits Exclusion Criteria: Individuals younger than 12 years of age Known allergy or sensitivity to study medication Inability to complete all study-related visits Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus control standard-of-care<br>Each person enrolled will be given fluocinonide 0.05% cream to apply twice daily to active areas. | Drug: fluocinonide 0.05% cream<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adherence Measures | There will be interim measures taken after the baseline measure at month 1, month 3, and at end point month 6. | up to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Severity Measures | 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). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic lupus, cutaneous lupus, systemic therapy, medication