Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid (RECOPB)

University Hospital, Rouen

Status and phase

Completed

Phase 4

Conditions

Bullous Pemphigoid

Treatments

Drug: Clobetasol Propionate cream treatment

Procedure: Impedance analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT02360202

2014/110/HP

2014-002804-26 (EudraCT Number)

Details and patient eligibility

About

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 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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