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

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ClinicalTrials.gov Identifier: NCT02360202
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Bullous Pemphigoid Procedure: Impedance analysis Drug: Clobetasol Propionate cream treatment Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid
Study Start Date : April 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus Steroids

Arm Intervention/treatment
Experimental: Bullous pemphigoid patient treated with clobetasol propionate
Impedance analysis in patient with bullous pemphigoid treated by Clobetasol Propionate cream treatment.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Weight variation between day 1 and day 30 [ Time Frame: Day 30 ]
  3. Urinary Sodium level variation between day 1 and day 30 [ Time Frame: Day 30 ]
  4. Urinary creatinin level variation between day 1 and day 30 [ Time Frame: Day 30 ]
  5. Brain Natriuretic Peptide level variation between day 1 and day 30 [ Time Frame: Day 30 ]
  6. 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

  7. Change from Baseline in bullous pemphigoid disease severity index at day 30 [ Time Frame: Day 30 ]
    BPDAI questionary assessment

  8. Change from Baseline in bullous pemphigoid disease severity index at day 7 [ Time Frame: Day 7 ]
    BPDAI questionary assessment

  9. Change from Baseline in corticoid administration dosage at days 30 [ Time Frame: Day 30 ]
    Evaluation of corticoid dosage between day 1 and day 30



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360202


Contacts
Contact: Sophie Duvert Lehembre, Doctor 2 32 88 68 41 ext +33 sophie.duvert-lehembre@chu-rouen.fr
Contact: Pascal JOLY, Professor 2 32 88 68 41 ext +33 pascal.joly@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: Sophie Duvert Lehembre, MD         
Sponsors and Collaborators
University Hospital, Rouen
Société de Dermatologie Française
Investigators
Principal Investigator: Sophie Duvert Lehembre, Doctor clinique dermatologique du chu de Rouen

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02360202     History of Changes
Other Study ID Numbers: 2014/110/HP
2014-002804-26 ( EudraCT Number )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs