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

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.

Study Overview

• Status: Completed
• Conditions: Bullous Pemphigoid
• Intervention / Treatment: Procedure: Impedance analysis; Drug: Clobetasol Propionate cream treatment

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bullous pemphigoid patient treated with clobetasol propionate; Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.

Procedure: Impedance analysis; 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; Drug: Clobetasol Propionate cream treatment; clobetasol propionate treatment initiated following French recommendations; Other Names: DERMOVAL or CLARELUX cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in fluid retention at day 30	Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in fluid retention at day 7	Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis	Day 7
Weight variation between day 1 and day 30		Day 30
Urinary Sodium level variation between day 1 and day 30		Day 30
Urinary creatinin level variation between day 1 and day 30		Day 30
Brain Natriuretic Peptide level variation between day 1 and day 30		Day 30
Change from Baseline in nutritional parameters at day 30	bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index	Day 30
Change from Baseline in bullous pemphigoid disease severity index at day 30	BPDAI questionary assessment	Day 30
Change from Baseline in bullous pemphigoid disease severity index at day 7	BPDAI questionary assessment	Day 7
Change from Baseline in corticoid administration dosage at days 30	Evaluation of corticoid dosage between day 1 and day 30	Day 30

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: Société de Dermatologie Française
• Investigators: Principal Investigator: Sophie Duvert Lehembre, Doctor, clinique dermatologique du chu de Rouen

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2015
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimated): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin Diseases, Vesiculobullous; Skin and Connective Tissue Diseases; Pemphigoid, Bullous; Investigative Techniques; Chemistry Techniques, Analytical; Weights and Measures; Quartz Crystal Microbalance Techniques
• Other Study ID Numbers: 2014/110/HP; 2014-002804-26 (EudraCT Number)