NCT04356014

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 21, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

April 16, 2020

Last Update Submit

April 19, 2020

Conditions

Systemic Lupus ErythematosusLichen Planus

Keywords

Palmoplantar keratoderma with livid telangiectatic erythemaSystemic lupusSubacute lupus erythematosus

Outcome Measures

Primary Outcomes (2)

  • Determine clinic immunologic features

    Determine clinic immunologic features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE.

    1 day

  • Determine clinic histopathologic features

    Epidemiologic clinic immunologic histopathologic data

    1 day

Secondary Outcomes (2)

  • Different therapeutics used

    1 day

  • Different therapeutics efficacy assessment

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients suffering from SLE or SCLE with palmar and or plantar keratoderma with livid telangiectatic erythema

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

paraffin-embedded and frozen cuteaneous biopsy specimens

MeSH Terms

Conditions

Lupus Erythematosus, SystemicLichen Planus

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLichenoid EruptionsSkin Diseases, PapulosquamousSkin Diseases

Study Officials

  • Didier BESSIS, PhD

    University Hospitals of Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

April 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

April 21, 2020

Record last verified: 2020-03

Locations

FR(1)