Erosive Pustular Dermatosis of the LegClin-EPDLNCT03623191
Clinical Aspect of Erosive Pustular Dermatosis of the Leg
An observational study of Erosive Pustular Dermatosis of the Leg, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Pustular Dermatosis of the Leg
- What is being tested?
- Clinical examination
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2013to 1 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients with erosive pustular dermatosis of the leg
Who may be able to join
- 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)
Who cannot join
- age < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The primary objective of this investigation was to describe the different clinical aspects of cases of Erosive pustular dermatosis of the leg.
- Conditions
- Erosive Pustular Dermatosis of the Leg
- Being tested
- Clinical examination
- Keywords
- Erosive pustular dermatosis of the leg, Erosive pustular dermatosis of the scalp, Venous insufficiency
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with erosive pustular dermatosis of the leg | Not described Receives: Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions location
Anterior or posterior leg face
Measured: Day 0
number of lesions
Less than 10 erosions, between 10 and 50 erosions and more than 50 erosions
Measured: 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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Sep 2013
- Primary completion1 Oct 2014
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erosive Pustular Dermatosis of the LegStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623191
- Sponsor's protocol ID
- 2017Ao006
- Acronym
- Clin-EPDL
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28532589
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Aspect of Erosive Pustular Dermatosis of the Leg
- ClinicalTrials.gov ID
- NCT03623191
- Acronym / sponsor ID
- Clin-EPDL / 2017Ao006
- Conditions
- Erosive Pustular Dermatosis of the Leg
- Keywords
- Erosive pustular dermatosis of the leg, Erosive pustular dermatosis of the scalp, Venous insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with erosive pustular dermatosis of the leg | – | Other: Clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with erosive pustular dermatosis of the leg
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examination | Other | Patients with erosive pustular dermatosis of the leg |
Primary outcome
Lesions location
Time frame: Day 0
Anterior or posterior leg face
number of lesions
Time frame: Day 0
Less than 10 erosions, between 10 and 50 erosions and more than 50 erosions
Presence of chronic venous insufficiency
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 28532589Nicol 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Pustular Dermatosis of the Leg, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesions location (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.