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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. Read our disclaimer for details. Identifier: NCT02176148
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : August 27, 2019
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment
Cutaneous Lupus 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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cutaneous Lupus Medication Experience Study
Study Start Date : December 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Disease Severity Measures [ Time Frame: 6 months ]

    Assessments will be taken at baseline, month 1, month 3, and at end point month 6.

    1. 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.
    2. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02176148

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United States, North Carolina
Wake Forest University School of Medicine - Department of Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: William W Huang, MD, MPH, FAAD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT02176148     History of Changes
Other Study ID Numbers: IRB00026573
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
cutaneous lupus
systemic lupus
systemic therapy
Additional relevant MeSH terms:
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Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents