Cutaneous Lupus Medication Experience Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cutaneous Lupus
• Intervention / Treatment: Drug: fluocinonide 0.05% cream

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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine - Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Dermatology clinic patients with a diagnosis of active cutaneous lupus confirmed by a dermatologist

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: William W Huang, MD, MPH, FAAD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 4, 2020
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (Estimated): June 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: medication; systemic therapy; cutaneous lupus; systemic lupus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Fluocinonide
• Other Study ID Numbers: IRB00026573

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No