Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

Overview

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.

Full Title of Study: “Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Change from Baseline in fluid retention at day 7
    • Time Frame: 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
    • 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
    • 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
    • Time Frame: Day 30
    • BPDAI questionary assessment
  • Change from Baseline in bullous pemphigoid disease severity index at day 7
    • Time Frame: Day 7
    • BPDAI questionary assessment
  • Change from Baseline in corticoid administration dosage at days 30
    • Time Frame: Day 30
    • Evaluation of corticoid dosage between day 1 and day 30

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Rouen
  • Collaborator
    • Société de Dermatologie Française
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sophie Duvert Lehembre, Doctor, Principal Investigator, clinique dermatologique du chu de Rouen
  • Overall Contact(s)
    • Sophie Duvert Lehembre, Doctor, 2 32 88 68 41, sophie.duvert-lehembre@chu-rouen.fr

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