Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Telangiectatic Palmoplantar Keratoderma in Systemic and Subacute Lupus Erythematosus : to a Form of Lichen Planus-like Lupus Erythematosus ?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04356014
• Other study ID #: RECHMPL20_0206
• Status: Active, not recruiting
• Start date: April 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine clinic immunologic features	Determine clinic immunologic features of patients with PPK and livid telangiectatic erythema-associated suffering from SLE and SCLE.	1 day
Primary	Determine clinic histopathologic features	Epidemiologic clinic immunologic histopathologic data	1 day
Secondary	Different therapeutics used	Describe the different therapeutics used. Report of the drug therapy used to heal acral keratoderma for each patient	1 day
Secondary	Different therapeutics efficacy assessment	Efficacy assessment of the treatments: total failure, partial remission, complete remission	1 day