Clinical Aspect of Erosive Pustular Dermatosis of the Leg

NCT03623191 | Completed

• 1 other identifier: 2017Ao006
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosive Pustular Dermatosis of the Leg

Keywords

Erosive pustular dermatosis of the leg; Erosive pustular dermatosis of the scalp; Venous insufficiency

Outcome Measures

Primary Outcomes (3)

• Lesions location

  Anterior or posterior leg face

  Day 0

• number of lesions

  Less than 10 erosions, between 10 and 50 erosions and more than 50 erosions

  Day 0

• Presence of chronic venous insufficiency

  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)

  Day 0

Study Arms (1)

Patients with erosive pustular dermatosis of the leg

Other: Clinical examination

Interventions

Clinical examination OTHER

Patients with erosive pustular dermatosis of the leg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with erosive pustular dermatosis of the leg

You may qualify if:

• \- 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)

You may not qualify if:

• \- age \< 18 years old

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

• Nicol P, Perceau G, Barbe C, Bernard P; members of GAD. Erosive pustular dermatosis of the leg: A prospective, multicentre, observational study of 36 cases. Ann Dermatol Venereol. 2017 Oct;144(10):582-588. doi: 10.1016/j.annder.2017.02.007. Epub 2017 May 19.

  PMID: 28532589 BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 9, 2018
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2015
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

FR (1)