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

Bullous Pemphigoid Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213421
• Other study ID #: 2000/014/HP
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: June 17, 2013
• Start date: August 2001
• Est. completion date: November 2008

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2008
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

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)

Locations

Country	Name	City	State
France	UH-rouen	Rouen	Seine maritime

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France,