Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus

NCT ID: NCT04356014

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Determine clinical immunological and histopathological features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE
2. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus Lichen Planus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \> 18 years old
* suffering from SLE or SCLE according to 2019 ACR/EULAR criteria
* With palmar and or plantar keratoderma with livid telangiectatic erythema

Exclusion Criteria

* \< 18 years old
* suffering from lupus lesions without SLE or SCLE criteria
* without palmar and or plantar keratoderma with livid telangiectatic erythema
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Didier BESSIS, PhD

Role: STUDY_DIRECTOR

University Hospitals of Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uh Montpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL20_0206

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Platelet Gel in Systemic Sclerosis
NCT00463125 UNKNOWN PHASE2/PHASE3