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Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356014
Recruitment Status : Active, not recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease
Systemic Lupus Erythematosus Lichen Planus

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:

  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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus : to a Form of Lichen Planus-like Lupus Erythematosus ?
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020





Primary Outcome Measures :
  1. 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.

  2. Determine clinic histopathologic features [ Time Frame: 1 day ]
    Epidemiologic clinic immunologic histopathologic data


Secondary Outcome Measures :
  1. Different therapeutics used [ Time Frame: 1 day ]
    Describe the different therapeutics used. Report of the drug therapy used to heal acral keratoderma for each patient

  2. Different therapeutics efficacy assessment [ Time Frame: 1 day ]
    Efficacy assessment of the treatments: total failure, partial remission, complete remission


Biospecimen Retention:   Samples With DNA
paraffin-embedded and frozen cuteaneous biopsy specimens


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients suffering from SLE or SCLE with palmar and or plantar keratoderma with livid telangiectatic erythema
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356014


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Didier BESSIS, PhD University Hospitals of Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04356014    
Other Study ID Numbers: RECHMPL20_0206
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Palmoplantar keratoderma with livid telangiectatic erythema
Systemic lupus
Subacute lupus erythematosus
Additional relevant MeSH terms:
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Keratoderma, Palmoplantar
Lupus Erythematosus, Systemic
Lichen Planus
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Keratosis