Cutaneous LupusNCT02176148
Cutaneous Lupus Medication Experience Study
An observational study of Cutaneous Lupus, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cutaneous Lupus
- What is being tested?
- fluocinonide 0.05% cream
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 4 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Dermatology clinic patients with a diagnosis of active cutaneous lupus confirmed by a dermatologist
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine - Department of Dermatology
Winston-Salem, North Carolina, 27157
About this 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.
Read the 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.
- Conditions
- Cutaneous Lupus
- Being tested
- fluocinonide 0.05% cream
- Keywords
- cutaneous lupus, systemic lupus, systemic therapy, medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluocinonide 0.05% creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Lupus control standard-of-care | Each person enrolled will be given fluocinonide 0.05% cream to apply twice daily to active areas. Receives: Drug: fluocinonide 0.05% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 month
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startDec 2014
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LupusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William W Huang, MD, MPH, FAAD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176148
- Sponsor's protocol ID
- IRB00026573
- Status last verified
- Apr 2025
- First submitted
- 24 Jun 2014
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Lupus Medication Experience Study
- ClinicalTrials.gov ID
- NCT02176148
- Acronym / sponsor ID
- IRB00026573
- Conditions
- Cutaneous Lupus
- Keywords
- cutaneous lupus, systemic lupus, systemic therapy, medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus control standard-of-care | – | Drug: fluocinonide 0.05% creamEach person enrolled will be given fluocinonide 0.05% cream to apply twice daily to active areas. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dermatology clinic patients with a diagnosis of active cutaneous lupus confirmed by a dermatologist
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluocinonide 0.05% cream | Drug | Lupus control standard-of-care |
Primary outcome
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.
1 secondary outcome
Disease Severity Measures
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W Huang, MD, MPH, FAAD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Lupus, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adherence Measures (time frame: up to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.