Cutaneous LupusADlupusNCT06506214
Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
An observational study of Cutaneous Lupus, run by University Hospital, Toulouse at 4 sites in France.
Trial summary
This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient relationship. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cutaneous Lupus
- What is being tested?
- Questionnaires
- How many people
- 202 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Oct 2022to 19 Jan 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus.
Who may be able to join
- Patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus
- No opposition to participation
- Patient able to complete the questionnaires
- Adult patient
Who cannot join
- Systemic lupus with multiple visceral involvement
- Cognitive or psychiatric disorders preventing the smooth running of the study
- Pregnant woman
- Patient under guardianship/curatorship or safeguard of justice
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital Montpellier
Montpellier, 34090
APHP Hôpital Saint-Louis
Paris, 75010
Hôpital Tenon
Paris, 75020
University Hospital Toulouse
Toulouse, 31400
About this study
Official title: Cross-sectional Multicenter Study Aimed at Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or higher on the Medical Adherence Self-Report Inventory scale.
Read the detailed description
This multicenter, cross-sectional study aims to characterize adherence to treatment and satisfaction of patients with cutaneous lupus. Non-adherence to treatment is a major problem, influenced by perception of the disease, fear of adverse effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or more on the visual analog scale of the Medical Adherence Self-Report Inventory questionnaire.
The study is descriptive, multicenter and cross-sectional. Participants will be adult patients suffering from cutaneous lupus, diagnosed by a dermatologist and under treatment, able to complete questionnaires. Patients with systemic lupus, cognitive or psychiatric disorders will be excluded from the study.
The inclusion period is two years, with 30 minutes of follow-up per participant. The study will provide a better understanding of the feelings of patients with cutaneous lupus and the factors limiting their adherence to treatment.
- Conditions
- Cutaneous Lupus
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Responses to questionnaires:
- Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
- Medical Adherence Self-Report Inventory (MASRI)
- Morisky Medication Adherence Scale (MMAS4)
- Visual analog scale (VAS) on the perception of disease control
- Belief on Medicine Questionnaire (BMQ)
- Care patient Feedback measure
- Hospital Anxiety and Depression Scale (HAD)
- Dermatology Life Quality Index (DLQI)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adherence to treatment of patients with cutaneous lupus.
Adherence is defined by a VAS greater than or equal to 80% on the Visual Analog Scale of the MASRI (Medical Adherence Self-Report Inventory) questionnaire.
Measured: Inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start8 Oct 2022
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carle PAUL, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506214
- Sponsor's protocol ID
- RC31/22/0298
- Acronym
- ADlupus
- Status last verified
- May 2026
- First submitted
- 11 Jul 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Multicenter Study Aimed at Characterizing Adherence to Treatment and Satisfaction With Care in Patients With Cutaneous Lupus
- ClinicalTrials.gov ID
- NCT06506214
- Acronym / sponsor ID
- ADlupus / RC31/22/0298
- Conditions
- Cutaneous Lupus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 17 Jul 2024 (actual)
- 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.
This multicenter study aims to evaluate treatment adherence and satisfaction of patients with cutaneous lupus, influenced by perception of the disease, fear of side effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or higher on the Medical Adherence Self-Report Inventory scale.
Detailed description
This multicenter, cross-sectional study aims to characterize adherence to treatment and satisfaction of patients with cutaneous lupus. Non-adherence to treatment is a major problem, influenced by perception of the disease, fear of adverse effects, cost of medications and the doctor-patient relationship. Adherence will be measured by a VAS of 80% or more on the visual analog scale of the Medical Adherence Self-Report Inventory questionnaire.
The study is descriptive, multicenter and cross-sectional. Participants will be adult patients suffering from cutaneous lupus, diagnosed by a dermatologist and under treatment, able to complete questionnaires. Patients with systemic lupus, cognitive or psychiatric disorders will be excluded from the study.
The inclusion period is two years, with 30 minutes of follow-up per participant. The study will provide a better understanding of the feelings of patients with cutaneous lupus and the factors limiting their adherence to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus.
Key inclusion criteria (4 listed)
- Patients with cutaneous lupus (pure cutaneous or subacute) diagnosed by a dermatologist and under local and/or systemic treatment for cutaneous lupus
- No opposition to participation
- Patient able to complete the questionnaires
- Adult patient
Key exclusion criteria (4 listed)
- Systemic lupus with multiple visceral involvement
- Cognitive or psychiatric disorders preventing the smooth running of the study
- Pregnant woman
- Patient under guardianship/curatorship or safeguard of justice
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 |
|---|---|---|
| QuestionnairesResponses to questionnaires: * Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) * Medical Adherence Self-Report Inventory (MASRI) * Morisky Medication Adherence Scale (MMAS4) * Visual analog scale (VAS) on the perception of disease control * Belief on Medicine Questionnaire (BMQ) * Care patient Feedback measure * Hospital Anxiety and Depression Scale (HAD) * Dermatology Life Quality Index (DLQI) | Other | Study group |
Primary outcome
Evaluation of adherence to treatment of patients with cutaneous lupus.
Time frame: Inclusion day
Adherence is defined by a VAS greater than or equal to 80% on the Visual Analog Scale of the MASRI (Medical Adherence Self-Report Inventory) questionnaire.
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 12 May 2026.
- Individual participant dataSharing planned: No
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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.
Carle PAUL, MD principal investigator
University Hospital, Toulouse
4 sites 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 University Hospital, Toulouse at 4 sites in France.
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 4 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Evaluation of adherence to treatment of patients with cutaneous lupus. (time frame: Inclusion day). 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 12 May 2026.