One-Dose hope for blistering skin disease?
NCT ID NCT00525616
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single cycle of rituximab can control bullous pemphigoid, a severe blistering skin condition. Eighteen adults with steroid-dependent or relapsing disease were enrolled. Researchers checked disease control weekly for a month and then monthly for two years, while also monitoring side effects.
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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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18 people
The number who actually took part.
- Start date
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Dec 2008
- Finished
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Dec 2013
- 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 to 80 years
- 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: * age \>= 18 and \< 80 * karnofsky \>= 50% * bullous pemphigoid clinical indication * cortico-dependent bullous pemphigoid in relapse for the second time * contraception used in female patient * consent obtained from patient Exclusion Criteria: * localized bullous pemphigoid in relapse (\<400cm2) * pemphigoid of pregnancy * dermatosis with IgA * pemphigoid with mucous damage * pregnant woman or nursing mother * woman able to have a baby and without contraception during the clinical trial period * age \< 18 or \> 80 * karnovsky \< 50% * significant disease or uncontrolled disease * serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody * patient with depletion lymphocytic treatment or with initial rituximab treatment * unstable angina or ischemic heart disease * cardiac insufficiency * cardiac rhythm trouble uncontrolled * evolutive infection * immunodepression * neutrophil polynuclear in blood \< 1.5 G/l and /or platelet blood concentration \< 75G/l * positive HIV serology * positive hepatitis B and / or C serology * concomitant immunodepressor treatment able to induce depletion lymphocytic treatment * no consentment * antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection * antecedent of deep tissue infection occurred the previous year of inclusion
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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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Rouen University Hospital, Direction de la Recherche et de l'Innovation,
Rouen, 76031, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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