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Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213421
First received: September 13, 2005
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  Purpose

to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.


Condition Intervention Phase
Bullous Pemphigoid
 Drug: Dermoval
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Pemphigus
U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Enrollment: 330
Study Start Date: August 2001
Study Completion Date: November 2008
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: Dermoval
group 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight < 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight > 45kg or for multibullous form with weight < 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth > 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d)
2 Drug: Dermoval
group 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight < 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight > 45kg or for multibullous form with weight < 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth > 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with compatible bullous pemphigoid clinical exam

Criteria

Inclusion Criteria:

  • age > 18
  • immunoflurescence, histological exam, predictive value according to bullous pemphigus diagnostic
  • consentment patient

Exclusion Criteria:

  • age < 18
  • no consentment
  • localized bullous pemphigus (<400cm2)
  • linear IgA pemphigus
  • corticothérapy, immunotherapy
  • pregnant woman pemphigus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213421

Locations
France
UH-rouen
Rouen, Seine maritime, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pascal Joly, MD-PHD UH Rouen
  More Information

No publications provided

Responsible Party: JOLY Pascal / Professor, UH of ROUEN
ClinicalTrials.gov Identifier: NCT00213421     History of Changes
Other Study ID Numbers: 2000/014/HP
Study First Received: September 13, 2005
Last Updated: February 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013