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New study tests easier treatment for blistering skin disease

NCT ID NCT02313870

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

322 people

The number who actually took part.

Started

Jan 2008

Finished

Dec 2015

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • University Hospital Of Montpellier

    Montpellier, 34295, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.