Erosive Pustular Dermatosis of the Leg Clinical Trial
— Clin-EPDLOfficial title:
Clinical Aspect of Erosive Pustular Dermatosis of the Leg
| NCT number | NCT03623191 |
| Other study ID # | 2017Ao006 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 1, 2013 |
| Est. completion date | June 1, 2015 |
| Verified date | August 2018 |
| Source | CHU de Reims |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | June 1, 2015 |
| Est. primary completion date | October 1, 2014 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Damien JOLLY | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Lesions location | Anterior or posterior leg face | Day 0 | |
| Primary | number of lesions | Less than 10 erosions, between 10 and 50 erosions and more than 50 erosions | Day 0 | |
| Primary | 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 |