| Trial name or title |
NPB‐01 (intravenous immunoglobulin) therapy for patients with bullous pemphigoid unresponsive to corticosteroids: Randomized, double‐blind, placebo control, parallel assignment study (phase II) |
| Methods |
Randomised, double‐blind (subject, investigator), placebo‐control, parallel assignment, safety/efficacy study |
| Participants |
20 participants with bullous pemphigoid |
| Interventions |
NPB‐01 Intravenous immunoglobulin versus placebo physiological saline |
| Outcomes |
Skin lesion area (%), number of new blisters/day, pemphigoid activity score, pemphigus disease area Index(PDAI), anti‐BP180 and ‐BP230 antibody titers, steroid dose, time to escape from the protocol and its ratio (time frame: 57 days) (designated as safety issue: no)
|
| Starting date |
December 2008 |
| Contact information |
Yasumasa Ogawa (kaihatsu@nihon‐pharm.co.jp)
Nihon Pharmaceutical Co. Ltd
Japan |
| Notes |
‐ |
