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Pemphigoid, Bullous clinical trials

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NCT ID: NCT02360202 Recruiting - Bullous Pemphigoid Clinical Trials

Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

RECOPB
Start date: April 2015
Phase: Phase 4
Study type: Interventional

Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.

NCT ID: NCT02313870 Completed - Bullous Pemphigoid Clinical Trials

Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid

BP/MTX
Start date: January 22, 2008
Phase: Phase 3
Study type: Interventional

This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.

NCT ID: NCT02226146 Completed - Pemphigoid, Bullous Clinical Trials

Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid

Start date: February 2016
Phase: Phase 2
Study type: Interventional

This is an open-label, proof-of-concept, single group study in adult patients with newly diagnosed, moderate to extensive BP. The study will consist of three periods: a screening period of up to 2 weeks, an open-label treatment period lasting 4 weeks consisting of IV infusion of bertilimumab on Days 0 and 14 and 28, and a safety and efficacy follow-up period of approximately 13 weeks. Patients will receive concomitant oral steroids during the treatment and follow-up period.

NCT ID: NCT02126020 Withdrawn - Clinical trials for Stevens-Johnson Syndrome

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several causes of corneal blindness. Some categories of patients, including those with auto-immune diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous membrane pemphigoid, have a higher risk of failure for the KPro. Because of chronic inflammation, the cornea supporting the KPro may melt, leading to a higher risk of infection, loss of the KPro and loss of the eye. Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to control inflammation in several diseases. It has been used in some cases of corneal melting with significant success. This study's hypothesis is that infliximab can be successfully used as an eye drop (instead of the usual administration through veins) and that its regular use may prevent melt in eyes with a Boston Keratoprosthesis type I and underlying auto-immune disease.

NCT ID: NCT01705795 Completed - Pemphigoid, Bullous Clinical Trials

Anti-IL-5 Therapy in Bullous Pemphigoid (BP)

Start date: February 13, 2013
Phase: Phase 2
Study type: Interventional

Randomized, placebo-controlled, double-blind study evaluating the effect of anti-IL-5-therapy in patients with bullous pemphigoid. The primary study objective is to determine the efficacy of an anti-IL-5 monoclonal antibody therapy, administered as 750mg mepolizumab, in patients with bullous pemphigoid.

NCT ID: NCT01688882 Terminated - Bullous Pemphigoid Clinical Trials

Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment

Start date: January 2013
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is broken down by the body and the impact it has on different blood and tissue markers will also be explored.

NCT ID: NCT01582880 Completed - Clinical trials for Rheumatoid Arthritis

Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

NCT ID: NCT01571895 Terminated - Bullous Pemphigoid Clinical Trials

Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid

Start date: February 20, 2012
Phase: Phase 2
Study type: Interventional

The objective of this clinical trial was to evaluate whether DF2156A has a potential in improving the clinical outcome in patients with active blistering bullous pemphigoid (BP) to warrant its further development. The safety of DF2156A in the specific clinical setting was also evaluated.

NCT ID: NCT01559155 Terminated - Pemphigus Clinical Trials

Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid

Start date: November 5, 2013
Phase:
Study type: Observational

The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.

NCT ID: NCT01408550 Completed - Bullous Pemphigoid Clinical Trials

Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids

Start date: August 2011
Phase: Phase 3
Study type: Interventional

Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area index (PDAI) and pemphigoid activity score involving skin lesion area and Number of new blisters. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 57 days after the start of the study treatment.