Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid (EDP-PB)
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ClinicalTrials.gov Identifier: NCT02837965
Recruitment Status : Unknown
Verified July 2016 by CHU de Reims. Recruitment status was: Recruiting
The study is an observational, multi-center, prospective, non-interventional and open-label data collection study assessing outcomes, treatment patterns, adverse events and costs in patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year with a follow-up (observation period) of 1 year for each patient. Four dermatology centres in France will participate. The hypothesis to be answered by the study is that superpotent topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world life as recommended by French guidelines and whether this treatment influences the medical costs by comparison with systemic therapies (e.g. methotrexate or prednisone).
Condition or disease
Drug: treatment with topical superpotent corticosteroid therapyDrug: treatment with systemic therapy (methotrexate)Drug: treatment systemic therapy (prednisone)Drug: treatment with systemic therapy (prednisone)Drug: treatment with systemic therapy (doxycycline)
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients with bullous pemphigoid
Written informed consent from the patient or a legally authorized representative person.
Patients affiliated to social security system
BP newly diagnosed according to the following criteria: i) suggestive clinical features; ii) histological picture of subepidermal blisters with an infiltrate of eosinophils in the superficial dermis; iii) presence of continuous, linear deposits of IgG and C3 deposits along the skin basement membrane zone by direct IF.
Patients: no prior superpotent topical steroid therapy or systemic treatment for BP for more than 2 weeks