Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

NCT ID: NCT02360202

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-17
• Study Completion Date: 2017-02-28

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.

Conditions

Bullous Pemphigoid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION

Study Groups

Bullous pemphigoid patient treated with clobetasol propionate

Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.

Group Type: EXPERIMENTAL

Impedance analysis

Intervention Type: PROCEDURE

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

Clobetasol Propionate cream treatment

Intervention Type: DRUG

clobetasol propionate treatment initiated following French recommendations

Interventions

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

Intervention Type: PROCEDURE

Clobetasol Propionate cream treatment

clobetasol propionate treatment initiated following French recommendations

Intervention Type: DRUG

Other Intervention Names

DERMOVAL or CLARELUX cream

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société de Dermatologie Française

OTHER

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Duvert Lehembre, Doctor

Role: PRINCIPAL_INVESTIGATOR

clinique dermatologique du chu de Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2014-002804-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2014/110/HP

Identifier Type: -

Identifier Source: org_study_id