Bullous PemphigoidPhase 4RECOPBNCT02360202
Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid
A Phase 4 study testing Impedance analysis and Clobetasol Propionate cream treatment in people with Bullous Pemphigoid, run by University Hospital, Rouen at 1 site in France.
Trial summary
Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Impedance analysis and Clobetasol Propionate cream treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2015to 28 Feb 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with age higher than 18
- Patient with bullous pemphigoid,
- Patient treated by local corticosteroid therapy (clobetasol propionate cream) but not yet processed or for less than 48 hours,
- Signed informed consent.
- Patient affiliated to Social Security Regimen
- Effective contraception in women of childbearing age (for postmenopausal women, confirmatory diagnosis of menopause will be collected)
Who cannot join
- Concomitant treatment with corticosteroids
- Recent introduction or recent (<6 weeks) treatment with diuretics, angiotensin-converting enzyme, receptor antagonist or anti-angiotensin renin (aliskiren)
- contraindication to the use of Clobetasol propionate (DERMOVAL and CLARELUX)
- Patient on salt diet (<or = to 5 g / d)
- Patients carry a defibrillator or a pace maker
- Amputated Patient
Show all 12Show fewer
- Pregnant and lactating
- Patient with Urinary Incontinency
- Recent heart decompensation in the last 6 weeks
- known Nephrotic Syndrome
- known or Severe hepatic impairment
- Hypoalbuminaemia less than 20 g / l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid
Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.
Read the detailed description
The main objective of the study is to evaluate whether there is fluid retention after introduction of clobetasol propionate treatment from 10 g/day dosage to 40 g / day in patients with bullous pemphigoid. Bio-impedance is a noninvasive device for measuring with an electric current of low intensity the different volumes of the human body. A preliminary experiment of impedance measurements in some patients with bullous pemphigoid (examination requested as part of a nutritional assessment) showed that these patients had mostly a total water loss without dehydration, corresponding to a significant undernutrition during 1 month of treatment, possibly related to muscle wasting and protein loss by skin erosions without obvious argument for fluid retention, justifying reproduce these measures on a larger number of patients and the other to accurately assess the evolution of nutritional parameters during the first month of treatment.
- Conditions
- Bullous Pemphigoid
- Being tested
- Impedance analysis, Clobetasol Propionate cream treatment
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance analysisProcedure or surgery
Impedance analysis in patient with Bullous pemphigoid disease treated with clobetasol propionate.
impedance analysis includes : fat measures, lean body mass, total body water, extracellular water phase angle
Clobetasol Propionate cream treatmentDrug
Also called DERMOVAL or CLARELUX cream
clobetasol propionate treatment initiated following French recommendations
| Study group | Role | What they receive |
|---|---|---|
| Bullous pemphigoid patient treated with clobetasol propionate | Experimental | Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment. Receives: Procedure: Impedance analysis; Drug: Clobetasol Propionate cream treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in fluid retention at day 30
Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis
Measured: Day 30
Secondary outcomes (9)
Change from Baseline in fluid retention at day 7
Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis
Measured: Day 7
Weight variation between day 1 and day 30
Measured: Day 30
Urinary Sodium level variation between day 1 and day 30
Measured: Day 30
Urinary creatinin level variation between day 1 and day 30
Measured: Day 30
Brain Natriuretic Peptide level variation between day 1 and day 30
Measured: Day 30
Change from Baseline in nutritional parameters at day 30
bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index
Measured: Day 30
Change from Baseline in bullous pemphigoid disease severity index at day 30
BPDAI questionary assessment
Measured: Day 30
Change from Baseline in bullous pemphigoid disease severity index at day 7
BPDAI questionary assessment
Measured: Day 7
Change from Baseline in corticoid administration dosage at days 30
Evaluation of corticoid dosage between day 1 and day 30
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start17 Feb 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française
- Responsible party
- Sponsor
- Investigators
- Sophie Duvert Lehembre, Doctor, Principal investigator, clinique dermatologique du chu de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360202
- Sponsor's protocol ID
- 2014/110/HP
- Other IDs
- 2014-002804-26, 2014
- Acronym
- RECOPB
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2015
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT02360202
- Acronym / sponsor ID
- RECOPB / 2014/110/HP
- Conditions
- Bullous Pemphigoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Société de Dermatologie Française
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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.
Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.
Detailed description
The main objective of the study is to evaluate whether there is fluid retention after introduction of clobetasol propionate treatment from 10 g/day dosage to 40 g / day in patients with bullous pemphigoid. Bio-impedance is a noninvasive device for measuring with an electric current of low intensity the different volumes of the human body. A preliminary experiment of impedance measurements in some patients with bullous pemphigoid (examination requested as part of a nutritional assessment) showed that these patients had mostly a total water loss without dehydration, corresponding to a significant undernutrition during 1 month of treatment, possibly related to muscle wasting and protein loss by skin erosions without obvious argument for fluid retention, justifying reproduce these measures on a larger number of patients and the other to accurately assess the evolution of nutritional parameters during the first month of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bullous pemphigoid patient treated with clobetasol propionate | Experimental | Procedure: Impedance analysis, Drug: Clobetasol Propionate cream treatmentImpedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with age higher than 18
- Patient with bullous pemphigoid,
- Patient treated by local corticosteroid therapy (clobetasol propionate cream) but not yet processed or for less than 48 hours,
- Signed informed consent.
- Patient affiliated to Social Security Regimen
Key exclusion criteria (12 listed)
- Concomitant treatment with corticosteroids
- Recent introduction or recent (<6 weeks) treatment with diuretics, angiotensin-converting enzyme, receptor antagonist or anti-angiotensin renin (aliskiren)
- contraindication to the use of Clobetasol propionate (DERMOVAL and CLARELUX)
- Patient on salt diet (<or = to 5 g / d)
- Patients carry a defibrillator or a pace maker
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 |
|---|---|---|
| Impedance analysisImpedance analysis in patient with Bullous pemphigoid disease treated with clobetasol propionate. impedance analysis includes : fat measures, lean body mass, total body water, extracellular water phase angle | Procedure or surgery | Bullous pemphigoid patient treated with clobetasol propionate |
| Clobetasol Propionate cream treatmentAlso: DERMOVAL or CLARELUX creamclobetasol propionate treatment initiated following French recommendations | Drug | Bullous pemphigoid patient treated with clobetasol propionate |
Primary outcome
Change from Baseline in fluid retention at day 30
Time frame: Day 30
Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis
9 secondary outcomes
Change from Baseline in fluid retention at day 7
Time frame: Day 7
Weight variation between day 1 and day 30
Time frame: Day 30
Urinary Sodium level variation between day 1 and day 30
Time frame: Day 30
Urinary creatinin level variation between day 1 and day 30
Time frame: Day 30
Brain Natriuretic Peptide level variation between day 1 and day 30
Time frame: Day 30
Change from Baseline in nutritional parameters at day 30
Time frame: Day 30
Change from Baseline in bullous pemphigoid disease severity index at day 30
Time frame: Day 30
Change from Baseline in bullous pemphigoid disease severity index at day 7
Time frame: Day 7
Change from Baseline in corticoid administration dosage at days 30
Time frame: Day 30
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 5 Feb 2026.
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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.
Sophie Duvert Lehembre, Doctor principal investigator
clinique dermatologique du chu de Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Impedance analysis and Clobetasol Propionate cream treatment in people with Bullous Pemphigoid, run by University Hospital, Rouen 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 6 inclusion and 12 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 5 Feb 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in fluid retention at day 30 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.