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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213421
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
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.
Information provided by (Responsible Party):
University Hospital, Rouen
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213421     History of Changes
Other Study ID Numbers: 2000/014/HP
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 18, 2013
Last Verified: June 2013

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