Cutaneous Lupus Medication Experience Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 12/23/2018 |
| Start Date: | December 2014 |
| End Date: | December 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Principal Investigator: William W Huang, MD,MPH,FAAD
Phone: 336-716-3775
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