New study tests easier treatment for blistering skin disease
NCT ID NCT02313870
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two ways to treat bullous pemphigoid, a severe blistering skin condition. One group used strong steroid creams for 9 months, while the other used steroids plus methotrexate for 4 weeks, then methotrexate alone for 8 months. The goal was to see if the combination treatment works as well as steroids alone, but is easier to manage. 322 adults took part in this phase 3 trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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322 people
The number who actually took part.
- Started
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Jan 2008
- Finished
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Dec 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects aged 18 years old or more * Patients affiliated to social security system, * Bullous pemphigoid diagnosed according to the following criteria: presence of at least 3 of the 4 clinical criteria for bullous pemphigoid as published by the french group for study of blistering diseases (positive predictive value: 95 %: age over 70 years, no lesions on neck or head, absence of atrophic scars, no mucosal lesions.= Histological Examination consistent with BP diagnosis and carried out in the month before inclusion: existence of a sub epidermal blister regardless of its size, containing neutrophils and / or eosinophils associated with a dermal infiltrate consisting of neutrophils and / or eosinophils, or to margination of neutrophils and / or eosinophils along the dermoepidermal junction.= Direct immunofluorescence performed (DIF) in the month preceding inclusion and showing linear deposition of IgG and / or C3 along the dermo-epidermal junction. * Patients: = no prior topical steroid or superpotent topical steroids for less than 16 days using the same or equivalent dosage as the one used in the study a different regimen and this regardless of the clinical resultsOR receiving potent or superpotent topical steroids for at least 16 days with a different regimen than that used during the trial AND not controlled by this treatment (appearance of at least 3 new blisters per day) * written consent of the patient or, if not possible, certified by a third party, * effective contraception (oral or intrauterine device) set up at least one month before inclusion for women of childbearing age, * For women of reproductive age (age \<50 years), negative serum pregnancy test at inclusion * Serum albumin ≥ 25 g / L Exclusion Criteria: * Localized bullous pemphigoid (area \<400 cm2: 20 x 20 cm) * Major blood cytopenia: Hb ≤ 10 g / dl and / or leukocytes ≤ 3000 / mm3 and / or platelets ≤ 100,000 / mm3 * Creatinine Clearance appreciated by the formula MDRD \<30 ml / min * Serum albumin \<25 g / L * pregnancy-associated Pemphigoid * Linear IgA Dermatosis identified by DIF * Pemphigoid with clinically dominant mucosal lesions * Relapse of previously diagnosed pemphigoid and still receiving treatment or for whom treatment was stopped for less than six months * Known allergy to topical steroids and / or methotrexate * recent history of liver disease (within two years) regardless of its nature or presence of active liver disease (transaminases and / or alkaline phosphatase greater than twice the upper standard laboratory) * Chronic alcoholism (declared consumption of more than 60 g alcohol / day or approximately 0.5 L / day of wine) * patient receiving notoriously hepatotoxic drugs or that can interfere with metabolism or haematological toxicity of Methotrexate * Peptic ulcer proven by endoscopy performed during the last 15 days * Severe Active infection regardless of its nature * Evolutive neoplasia whatever its nature except basal cell carcinoma * Poorly controlled diabetes mellitus (fasting glucose greater than or equal to 2 2.5 g / L and / or Hb A1C greater than or equal to 8.5% before treatment) * disease that can not be possibly monitored on a regular basis * acquired or congénital Immunosuppression * known HIV Seropositivity * Chronic respiratory failure * Pregnancy or breastfeeding * Patient of childbearing age and not using effective contraception * Patient incapable of giving informed consent and for whom a family member or a trustworthy third party does not grant participation in the study, protected adults, vulnerable people (art. L1121-6, L1121-7, L 1121-8, L1121-9) or patient accrued in another clinical research study * Long-term treatment prescribed for another illness by steroids, immunosuppressive drugs, cyclosporin or any other treatment that may have been successfully used in the treatment of bullous pemphigoid (dapsone, Gamma globulins, plasma exchange, tetracyclines). For all previous medications, a minimum clearance of two months is required before enrollment in the present trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University Hospital Of Montpellier
Montpellier, 34295, France
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Other studies related to the condition(s) this trial covers.
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