Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02360202
Recruitment Status : Unknown
Verified August 2017 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : February 10, 2015
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE January 7, 2015
First Posted Date  ICMJE February 10, 2015
Last Update Posted Date August 30, 2017
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
Change from Baseline in fluid retention at day 30 [ Time Frame: Day 30 ]
Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
  • Change from Baseline in fluid retention at day 7 [ Time Frame: Day 7 ]
    Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis
  • Weight variation between day 1 and day 30 [ Time Frame: Day 30 ]
  • Urinary Sodium level variation between day 1 and day 30 [ Time Frame: Day 30 ]
  • Urinary creatinin level variation between day 1 and day 30 [ Time Frame: Day 30 ]
  • Brain Natriuretic Peptide level variation between day 1 and day 30 [ Time Frame: Day 30 ]
  • Change from Baseline in nutritional parameters at day 30 [ Time Frame: Day 30 ]
    bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index
  • Change from Baseline in bullous pemphigoid disease severity index at day 30 [ Time Frame: Day 30 ]
    BPDAI questionary assessment
  • Change from Baseline in bullous pemphigoid disease severity index at day 7 [ Time Frame: Day 7 ]
    BPDAI questionary assessment
  • Change from Baseline in corticoid administration dosage at days 30 [ Time Frame: Day 30 ]
    Evaluation of corticoid dosage between day 1 and day 30
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid
Official Title  ICMJE Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Bullous Pemphigoid
Intervention  ICMJE
  • Procedure: 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

  • Drug: Clobetasol Propionate cream treatment
    clobetasol propionate treatment initiated following French recommendations
    Other Name: DERMOVAL or CLARELUX cream
Study Arms  ICMJE Experimental: Bullous pemphigoid patient treated with clobetasol propionate
Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.
Interventions:
  • Procedure: Impedance analysis
  • Drug: Clobetasol Propionate cream treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2015)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02360202
Other Study ID Numbers  ICMJE 2014/110/HP
2014-002804-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Société de Dermatologie Française
Investigators  ICMJE
Principal Investigator: Sophie Duvert Lehembre, Doctor clinique dermatologique du chu de Rouen
PRS Account University Hospital, Rouen
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP