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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213421
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213421     History of Changes
Other Study ID Numbers: 2000/014/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 23, 2014