Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

Bullous Pemphigoid Clinical Trial

— RECOPB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02360202
• Other study ID #: 2014/110/HP
• Secondary ID: 2014-002804-26
• Status: Recruiting
• Phase: Phase 4
• First received: January 7, 2015
• Last updated: August 29, 2017
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: Sophie Duvert Lehembre, Doctor
• Phone: 2 32 88 68 41
• Email: sophie.duvert-lehembre[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Société de Dermatologie Française

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Weight variation between day 1 and day 30		Day 30
Secondary	Urinary Sodium level variation between day 1 and day 30		Day 30
Secondary	Urinary creatinin level variation between day 1 and day 30		Day 30
Secondary	Brain Natriuretic Peptide level variation between day 1 and day 30		Day 30
Secondary	Change from Baseline in nutritional parameters at day 30	bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index	Day 30
Secondary	Change from Baseline in bullous pemphigoid disease severity index at day 30	BPDAI questionary assessment	Day 30
Secondary	Change from Baseline in bullous pemphigoid disease severity index at day 7	BPDAI questionary assessment	Day 7
Secondary	Change from Baseline in corticoid administration dosage at days 30	Evaluation of corticoid dosage between day 1 and day 30	Day 30