Bullous pemphigoid Skin and Connective Tissue Diseases Pemphigoid
Conditions
Interventions
Prednisolone (0.5 mg/kg/day
oral) vs doxycycline (200 mg/day
oral)
The initial clinician-blinded phase will last for 6 weeks when participants will receive one of either prednisolone or doxycycline. After this 6 weeks the clinician will be able to adjust the
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged at least 18 years old 2. Able to provide written informed consent 3. Clinical features consistent with bullous pemphigoid 4. Either a direct or indirect (serum) immuno-fluorescence (linear IgG/C3 at epidermal basement membrane zone) positive for bullous pemphigoid 5. At least three significant blisters spread over two or more body sites that have appeared in the week prior to study enrolment 6. Free of blisters and any treatment for previous episodes of bullous pemphigoid for at least one year
Exclusion criteria
Exclusion criteria: 1. 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 for this episode is permitted. 2. Recent administration of a live virus vaccine 3. Mainly or entirely mucosal pemphigoid 4. Known allergy to tetracyclines 5. Presence of any condition which precludes the use of either of the study drugs 6. Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating 7. Has active cancer (apart from basal cell carcinoma and Bowen's disease) 8. Has any other condition which would, in the Investigator's opinion, deem the patient unsuitable for participation in the study 9. Taking part in any other intervention study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s) as of 05/04/2012: Absolute differences in the two treatment arms in the: 1. Proportion of participants classed as treatment success (3 or less significant blisters present on examination) at 6 weeks 2. Number of reported grade 3, 4 and 5 (mortality) adverse events for one year Previous primary outcome measure(s): Differences in the two treatment arms in the: 1. Proportion of participants classed as treatment success (3 or less significant blisters present on examination) at 6 weeks 2. Number of reported grade 3, 4 and 5 (mortality) adverse events for one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the two treatment arms in the: 1. Proportion of participants classed as treatment success (3 or less significant blisters present on examination) at 6 weeks and are alive at one year 2. Proportion of participants classed as treatment success (3 or less significant blisters present on examination) after 3 and 12 months of treatment 3. Proportion of participants who have a further episode of bullous pemphigoid during their participation in the study after previously being classed as a treatment success 4. Number of reported grade 1 and 2 adverse events for one year following the start of study treatment 5. Cost-effectiveness | — |
Countries
Germany, United Kingdom
Outcome results
None listed