Clinical trial NCT02360202: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bullous Pemphigoid
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Société de Dermatologie Française
First posted: 2015-02-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 (\<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

Primary outcomes:
measure: Change from Baseline in fluid retention at day 30
timeFrame: Day 30
Secondary outcomes:
measure: Change from Baseline in fluid retention at day 7
timeFrame: Day 7
measure: Weight variation between day 1 and day 30
timeFrame: Day 30
measure: Urinary Sodium level variation between day 1 and day 30
timeFrame: Day 30
measure: Urinary creatinin level variation between day 1 and day 30
timeFrame: Day 30
measure: Brain Natriuretic Peptide level variation between day 1 and day 30
timeFrame: Day 30
measure: Change from Baseline in nutritional parameters at day 30
timeFrame: Day 30
measure: Change from Baseline in bullous pemphigoid disease severity index at day 30
timeFrame: Day 30
measure: Change from Baseline in bullous pemphigoid disease severity index at day 7
timeFrame: Day 7
measure: Change from Baseline in corticoid administration dosage at days 30
timeFrame: Day 30
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: clinique dermatologique du chu de Rouen
name: Sophie Duvert Lehembre, Doctor
role: PRINCIPAL_INVESTIGATOR
References: