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Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

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Disease Information

Descriptive Information
Brief Title † Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid
Official Title † Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid
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.
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † Change from Baseline in fluid retention at day 30
Secondary Outcome Measure † Change from Baseline in fluid retention at day 7
Condition † Bullous Pemphigoid
Intervention † ProcedureImpedance analysis
Study Arms / Comparison Groups Bullous pemphigoid patient treated with clobetasol propionate Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 35
Start Date † April 2015
Completion Date December 2017
Primary Completion Date November 2017
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 (
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Sophie Duvert Lehembre, Doctor, 2 32 88 68 41, sophie.duvert-lehembre@chu-rouen.fr
Location Countries † France
Administrative Information
NCT ID † NCT02360202
Organization ID 2014/110/HP
Secondary IDs †† 2014-002804-26
Responsible Party Sponsor
Study Sponsor † University Hospital, Rouen
Collaborators †† Société de Dermatologie Française
Investigators † Principal Investigator: Sophie Duvert Lehembre, Doctor, clinique dermatologique du chu de Rouen
Information Provided By
Verification Date April 2015
First Received Date † January 7, 2015
Last Updated Date April 30, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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