Evaluation of Fluid Retention Due to Superpotent Topical... | NCT02360202

Studies
Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

NCT02360202

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Feb 5, 2026Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Bullous Pemphigoid

Interventions

Impedance analysis
Clobetasol Propionate cream treatment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-002804-26	EudraCT Number

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2015Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Feb 28, 2017Actual

First Submitted Date

Jan 7, 2015

First Submission Date that Met QC Criteria

Feb 4, 2015

First Posted Date

Feb 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 5, 2026Actual

Name	Class
Société de Dermatologie Française	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bullous pemphigoid patient treated with clobetasol propionate	Experimental	Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.	Procedure: Impedance analysis Drug: Clobetasol Propionate cream treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impedance analysis	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in fluid retention at day 30	Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis	Day 30

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in fluid retention at day 7	Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis	Day 7
Weight variation between day 1 and day 30

Other Outcomes

Not provided

Eligibility Module

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 (\

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sophie Duvert Lehembre, Doctor	clinique dermatologique du chu de Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital		Rouen		76031	France

Condition Browse Module

MeSH Terms

ID	Term
D010391	Pemphigoid, Bullous

Ancestor Terms

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058525	Quartz Crystal Microbalance Techniques

Ancestor Terms

ID	Term
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D014894	Weights and Measures

Browse Leaves

Not provided

Browse Branches

Not provided