A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid - Bullous Pemphigoid Steroids & Tetracyclines Study

Phase 1

• Conditions: BP is a serious condition with a significant associated morbidity and mortality rate. Widespread tense and haemorrhagic blisters, skin erosions and severe itching cause patients a great deal of distress and pain. It occurs mainly in the elderly. The mortality rate in treated patients is estimated to range from 20% - 40% at one year.; MedDRA version: 9.1Level: LLTClassification code 10006568Term: Bullous pemphigoid NOS; MedDRA version: 9.1Level: LLTClassification code 10006567Term: Bullous pemphigoid

• Registration Number: EUCTR2007-006658-24-DE
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-08
• Study Completion: 2014-10-31
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

•Aged at least eighteen years old.
•Able to provide written informed consent.
•Diagnosed with bullous pemphigoid defined as:
oClinical features consistent with bullous pemphigoid.
•To be eligible for the study, the patient will need to have either a positive direct or indirect immuno- fluorescence.
oDirect or indirect (serum) immuno-fluorescence (linear IgG/C3 at epidermal basement membrane zone) positive for bullous pemphigoid.
•At least three significant blisters at two or more body sites that have appeared in the week prior to study enrolment. Significant blisters are defined as intact blisters containing fluid which are at least 5mm in diameter. However, if the patient has popped a blister, or the blister is at a site that makes it susceptible to bursting such as the sole of the foot, it can be considered part of the blister count, providing there is a flexible (but not dry) roof present over a moist base.
•Free of blisters and any treatment for bullous pemphigoid for at least one year.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Received any of the study medications or other recognised systemic medications for the treatment of this episode of bullous pemphigoid prior to study entry. Prior topical treatment is permitted.
•Recent administration of a live virus vaccine.
•Mainly or entirely mucosal bullous pemphigoid.
•Known allergy to tetracyclines.
•Presence of any condition which precludes the use of either of the study drugs.
•Women who are taking the oral contraceptive pill, who are pregnant or plan to become pregnant during the study duration or lactating. Women of childbearing potential must be using adequate contraception and be prepared to avoid pregnancy while participating in the study.
•Cancer (apart from basal cell carcinoma).
•Has any other condition which would, in the Investigators opinion, deem the patient unsuitable for participation in the study.
•Taking part in any other intervention study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified