Clinical Aspect of Erosive Pustular Dermatosis of the Leg

Completed

• Conditions: Erosive Pustular Dermatosis of the Leg
• Interventions: Other: Clinical examination

• Registration Number: NCT03623191
• Lead Sponsor: CHU de Reims

Brief Summary

Erosive pustular dermatosis of the leg is a fairlyrecent clinical entity that was described the first time in 1987.

Diagnosis of erosive pustular dermatosis of the leg is made on clinical grounds. It presents as non-follicular pustules of variable size and numbers that rapidly give way to erosions and crusts on one or both legs, and which are found in particular on the anterior aspect of the middle third of the leg (. The lesions are of chronic progression, despite topical therapy. Erosive pustular dermatosis of the leg is seen in elderly patients, mainly female, and may be associated with chronic venous insufficiency or cutaneous atrophy. In the absence of specific criteria and because of the existence of misleading clinical forms, diagnosis is based upon exclusion.

Detailed Description

The primary objective of this investigation was to describe the different clinical aspects of cases of Erosive pustular dermatosis of the leg.

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2014-10-01
• Study Completion: 2015-06-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• non-follicular pustules and multiple erosions on one or both legs showing no evidence of improvement after application of compression in the event of clinical signs of chronic venous insufficiency and showing no improvement following treatment with local and/or systemic antibacterial therapy, fungal samples from the pustules negative on direct examination, negative direct immunofluorescence results for biopsy samples (taken from around the lesion)

Exclusion Criteria

• age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with erosive pustular dermatosis of the leg	Clinical examination	-

Primary Outcome Measures

Name	Time	Method
Lesions location	Day 0	Anterior or posterior leg face
number of lesions	Day 0	Less than 10 erosions, between 10 and 50 erosions and more than 50 erosions
Presence of chronic venous insufficiency	Day 0	Diagnosis based on the CEAP 2004 Score (Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, GloviczkiP, Kistner RL, et al. Revision of the CEAP classification forchronic venous disorders: consensus statement. J Vasc Surg2004;40:1248-52)

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France