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Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid (RECOPB)

Primary Purpose

Bullous Pemphigoid

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Impedance analysis

Clobetasol Propionate cream treatment

About this trial

This is an interventional prevention trial for Bullous Pemphigoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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
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

Sites / Locations

Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bullous pemphigoid patient treated with clobetasol propionate

Arm Description

Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.

Outcomes

Primary Outcome Measures

Change from Baseline in fluid retention at day 30

Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis

Secondary Outcome Measures

Change from Baseline in fluid retention at day 7

Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis

Weight variation between day 1 and day 30

Urinary Sodium level variation between day 1 and day 30

Urinary creatinin level variation between day 1 and day 30

Brain Natriuretic Peptide level variation between day 1 and day 30

Change from Baseline in nutritional parameters at day 30

bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index

Change from Baseline in bullous pemphigoid disease severity index at day 30

BPDAI questionary assessment

Change from Baseline in bullous pemphigoid disease severity index at day 7

BPDAI questionary assessment

Change from Baseline in corticoid administration dosage at days 30

Evaluation of corticoid dosage between day 1 and day 30

Full Information

NCT ID

NCT02360202

First Posted

January 7, 2015

Last Updated

August 29, 2017

Sponsor

University Hospital, Rouen

Collaborators

Société de Dermatologie Française

1. Study Identification

Unique Protocol Identification Number

NCT02360202

Brief Title

Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

Acronym

RECOPB

Official Title

Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

Collaborators

Société de Dermatologie Française

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bullous Pemphigoid

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bullous pemphigoid patient treated with clobetasol propionate

Arm Type

Experimental

Arm Description

Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.

Intervention Type

Procedure

Intervention Name(s)

Impedance analysis

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clobetasol Propionate cream treatment

Other Intervention Name(s)

DERMOVAL or CLARELUX cream

Intervention Description

clobetasol propionate treatment initiated following French recommendations

Primary Outcome Measure Information:

Title

Change from Baseline in fluid retention at day 30

Description

Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis

Time Frame

Day 30

Secondary Outcome Measure Information:

Title

Change from Baseline in fluid retention at day 7

Description

Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis

Time Frame

Day 7

Title

Weight variation between day 1 and day 30

Time Frame

Day 30

Title

Urinary Sodium level variation between day 1 and day 30

Time Frame

Day 30

Title

Urinary creatinin level variation between day 1 and day 30

Time Frame

Day 30

Title

Brain Natriuretic Peptide level variation between day 1 and day 30

Time Frame

Day 30

Title

Change from Baseline in nutritional parameters at day 30

Description

bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index

Time Frame

Day 30

Title

Change from Baseline in bullous pemphigoid disease severity index at day 30

Description

BPDAI questionary assessment

Time Frame

Day 30

Title

Change from Baseline in bullous pemphigoid disease severity index at day 7

Description

BPDAI questionary assessment

Time Frame

Day 7

Title

Change from Baseline in corticoid administration dosage at days 30

Description

Evaluation of corticoid dosage between day 1 and day 30

Time Frame

Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie Duvert Lehembre, Doctor

Phone

2 32 88 68 41

Ext

+33

sophie.duvert-lehembre@chu-rouen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal JOLY, Professor

Phone

2 32 88 68 41

Ext

+33

pascal.joly@chu-rouen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophie Duvert Lehembre, Doctor

Organizational Affiliation

clinique dermatologique du chu de Rouen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rouen University Hospital

City

Rouen

ZIP/Postal Code

76031

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie Duvert Lehembre, MD

12. IPD Sharing Statement

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Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

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