NCT02360202

Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-02-17
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2015-02-10
• Last updated: 2026-02-05

Locations

1 site across 1 country: France