Systemic Lupus ErythematosusNCT04356014
Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus and Lichen Planus, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) and subacute cutaneous lupus erythematosus (SCLE) is a rare phenomenon seldom reported in literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Lichen Planus
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from SLE or SCLE with palmar and or plantar keratoderma with livid telangiectatic erythema
Who may be able to join
- > 18 years old
- suffering from SLE or SCLE according to 2019 ACR/EULAR criteria
- With palmar and or plantar keratoderma with livid telangiectatic erythema
Who cannot join
- < 18 years old
- suffering from lupus lesions without SLE or SCLE criteria
- without palmar and or plantar keratoderma with livid telangiectatic erythema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus : to a Form of Lichen Planus-like Lupus Erythematosus ?
Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) and subacute cutaneous lupus erythematosus (SCLE) is a rare phenomenon seldom reported in literature. The investigators hypothesize that clinic-immunologic assessment and detailed investigation of cutaneous biopsy specimen of PPK and erythema of patients suffering from SLE and SCLE could lead to determine more precisely nosological settings of this injury. Report the different therapeutics with efficacy assessment could be helpful to highlight useful treatment for these patients.
Read the detailed description
Context: Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) is a rare phenomenon seldom reported in literature. To our knowledge no case has been described in subacute cutaneous lupus erythematosus (SCLE) so far. Pathogeny and etiologic origin are not clear: it could be no-specific cutaneous manifestation of SLE, verrucous chilblain lupus, lichen planus, discoid lupus erythematosus lesions, overlap syndrome or coexistence of both diseases.
Objective:
- Determine clinical immunological and histopathological features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE
- Describe the different therapeutics used and efficacy assessment Methods: Multicentric retrospective descriptive study reporting 14 patients with SLE or SCLE suffering from an acral livid erythematosus keratoderma, with clinical data regarding lupus erythematosus and acral keratoderma, immunological blood samples findings and histopathological results of keratoderma and livid erythema biopsies with direct immunofluorescence if performed. The treatments set down in order to heal are noted followed by efficacy assessment: total failure, partial remission, complete remission.
- Conditions
- Systemic Lupus Erythematosus, Lichen Planus
- Keywords
- Palmoplantar keratoderma with livid telangiectatic erythema, Systemic lupus, Subacute lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Lichen Planus
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine clinic immunologic features
Determine clinic immunologic features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE.
Measured: 1 day
Determine clinic histopathologic features
Epidemiologic clinic immunologic histopathologic data
Measured: 1 day
Secondary outcomes (2)
Different therapeutics used
Describe the different therapeutics used. Report of the drug therapy used to heal acral keratoderma for each patient
Measured: 1 day
Different therapeutics efficacy assessment
Efficacy assessment of the treatments: total failure, partial remission, complete remission
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier BESSIS, PhD, Study director, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356014
- Sponsor's protocol ID
- RECHMPL20_0206
- Status last verified
- Mar 2020
- First submitted
- 16 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus : to a Form of Lichen Planus-like Lupus Erythematosus ?
- ClinicalTrials.gov ID
- NCT04356014
- Acronym / sponsor ID
- RECHMPL20_0206
- Conditions
- Systemic Lupus Erythematosus, Lichen Planus
- Keywords
- Palmoplantar keratoderma with livid telangiectatic erythema, Systemic lupus, Subacute lupus erythematosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 21 Apr 2020 (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.
Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) and subacute cutaneous lupus erythematosus (SCLE) is a rare phenomenon seldom reported in literature. The investigators hypothesize that clinic-immunologic assessment and detailed investigation of cutaneous biopsy specimen of PPK and erythema of patients suffering from SLE and SCLE could lead to determine more precisely nosological settings of this injury. Report the different therapeutics with efficacy assessment could be helpful to highlight useful treatment for these patients.
Detailed description
Context: Palmoplantar keratoderma (PPK) associated to livid telangiectatic erythema during systemic lupus erythematosus (SLE) is a rare phenomenon seldom reported in literature. To our knowledge no case has been described in subacute cutaneous lupus erythematosus (SCLE) so far. Pathogeny and etiologic origin are not clear: it could be no-specific cutaneous manifestation of SLE, verrucous chilblain lupus, lichen planus, discoid lupus erythematosus lesions, overlap syndrome or coexistence of both diseases.
Objective:
- Determine clinical immunological and histopathological features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE
- Describe the different therapeutics used and efficacy assessment Methods: Multicentric retrospective descriptive study reporting 14 patients with SLE or SCLE suffering from an acral livid erythematosus keratoderma, with clinical data regarding lupus erythematosus and acral keratoderma, immunological blood samples findings and histopathological results of keratoderma and livid erythema biopsies with direct immunofluorescence if performed. The treatments set down in order to heal are noted followed by efficacy assessment: total failure, partial remission, complete remission.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from SLE or SCLE with palmar and or plantar keratoderma with livid telangiectatic erythema
Key inclusion criteria (3 listed)
- > 18 years old
- suffering from SLE or SCLE according to 2019 ACR/EULAR criteria
- With palmar and or plantar keratoderma with livid telangiectatic erythema
Key exclusion criteria (3 listed)
- < 18 years old
- suffering from lupus lesions without SLE or SCLE criteria
- without palmar and or plantar keratoderma with livid telangiectatic erythema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine clinic immunologic features
Time frame: 1 day
Determine clinic immunologic features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE.
Determine clinic histopathologic features
Time frame: 1 day
Epidemiologic clinic immunologic histopathologic data
2 secondary outcomes
Different therapeutics used
Time frame: 1 day
Different therapeutics efficacy assessment
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Didier BESSIS, PhD study director
University Hospitals of Montpellier
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 Systemic Lupus Erythematosus and Lichen Planus, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. 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 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?
Results are not available in the source record.
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?
Determine clinic immunologic features (time frame: 1 day). The study lists 2 primary outcomes in all. 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 21 Apr 2020.