NCT02360202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

February 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 7, 2015

Last Update Submit

February 4, 2026

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • Change from Baseline in fluid retention at day 7

    Day 7

  • Weight variation between day 1 and day 30

    Day 30

  • Urinary Sodium level variation between day 1 and day 30

    Day 30

  • Urinary creatinin level variation between day 1 and day 30

    Day 30

  • Brain Natriuretic Peptide level variation between day 1 and day 30

    Day 30

  • +4 more secondary outcomes

Study Arms (1)

Bullous pemphigoid patient treated with clobetasol propionate

EXPERIMENTAL

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

Procedure: Impedance analysisDrug: Clobetasol Propionate cream treatment

Interventions

Impedance analysisPROCEDURE

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

Bullous pemphigoid patient treated with clobetasol propionate
Clobetasol Propionate cream treatmentDRUG

clobetasol propionate treatment initiated following French recommendations

Also known as: DERMOVAL or CLARELUX cream
Bullous pemphigoid patient treated with clobetasol propionate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Quartz Crystal Microbalance Techniques

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesWeights and Measures

Study Officials

  • Sophie Duvert Lehembre, Doctor

    clinique dermatologique du chu de Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

February 10, 2015

Study Start

February 17, 2015

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

FR(1)