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Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bullous Pemphigoid

Intervention: Impedance analysis (Procedure); Clobetasol Propionate cream treatment (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Rouen

Official(s) and/or principal investigator(s):
Sophie Duvert Lehembre, Doctor, Principal Investigator, Affiliation: clinique dermatologique du chu de Rouen

Overall contact:
Sophie Duvert Lehembre, Doctor, Phone: 2 32 88 68 41, Ext: +33, Email: sophie.duvert-lehembre@chu-rouen.fr

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Change from Baseline in fluid retention at day 30

Secondary outcome:

Change from Baseline in fluid retention at day 7

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

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

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

Change from Baseline in corticoid administration dosage at days 30

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 (

- 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

Locations and Contacts

Sophie Duvert Lehembre, Doctor, Phone: 2 32 88 68 41, Ext: +33, Email: sophie.duvert-lehembre@chu-rouen.fr

Rouen University Hospital, Rouen 76031, France; Recruiting
Sophie Duvert Lehembre, MD
Additional Information

Starting date: April 2015
Last updated: April 30, 2015

Page last updated: August 23, 2015

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