Clinical trial NCT02176148: Cutaneous Lupus Medication Experience Study
Official title: Cutaneous Lupus Medication Experience Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Lupus
Keywords: cutaneous lupus
systemic lupus
systemic therapy
medication
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dermatology clinic patients with a diagnosis of active cutaneous lupus confirmed by a dermatologist

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.

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

Primary outcomes:
measure: Change in Adherence Measures
timeFrame: up to 6 month
Secondary outcomes:
measure: Disease Severity Measures
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine - Department of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: William W Huang, MD, MPH, FAAD
role: PRINCIPAL_INVESTIGATOR
References: