Bullous PemphigoidNCT00213421
Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus
An observational study of Bullous Pemphigoid, run by University Hospital, Rouen at 1 site in France.
Trial summary
to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Dermoval
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2001to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with compatible bullous pemphigoid clinical exam
Who may be able to join
- age > 18
- immunoflurescence, histological exam, predictive value according to bullous pemphigus diagnostic
- consentment patient
Who cannot join
- age < 18
- no consentment
- localized bullous pemphigus (<400cm2)
- linear IgA pemphigus
- corticothérapy, immunotherapy
- pregnant woman pemphigus
Trial locations and contacts
1 site in 1 country.
About this study
to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.
- Conditions
- Bullous Pemphigoid
- Being tested
- Dermoval
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermovalDrug
group 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight < 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight > 45kg or for multibullous form with weight < 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth > 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: Dermoval | |
| 2 | Not described Receives: Drug: Dermoval |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2001
- Primary completionOct 2004
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Joly, MD-PHD, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213421
- Sponsor's protocol ID
- 2000/014/HP
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus
- ClinicalTrials.gov ID
- NCT00213421
- Acronym / sponsor ID
- 2000/014/HP
- Conditions
- Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Oct 2004 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Dermoval |
| 2 | – | Drug: Dermoval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with compatible bullous pemphigoid clinical exam
Key inclusion criteria (3 listed)
- age > 18
- immunoflurescence, histological exam, predictive value according to bullous pemphigus diagnostic
- consentment patient
Key exclusion criteria (6 listed)
- age < 18
- no consentment
- localized bullous pemphigus (<400cm2)
- linear IgA pemphigus
- corticothérapy, immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermovalgroup 1 elevated corticosteroids : attack treatment 2 tubes of 10g (4t/d) decreasing treatment : one month: 2 tubes/J (2t/d); 2 months : 2 tubes 1d sur 2 (1d/j); 4 months : 2 tubes 2 fois /week (0,6t/d); 4 months : 2 tubes 1 fois /week (0,3t/d)fois /week (0,3t/d) group 2 low corticosteroids : for paucibullous form with weight < 45kg attack treatment 1 tubes of 10g (1t/d)decreasing treatment 1 month : 1 tube every 2d (0,5t/d; 1 month : 1 tubes 2 fois /week (0,3t/d) 1 month : 1 tubes 1 fois/week (0,15t/d); for paucibullous form with weight > 45kg or for multibullous form with weight < 45kg attack treatment 2 tubes of 10g (2t/d)decreasing treatment 1 month : 2 tubes every 2j (1t/d; 1 month : 2 tubes 2 fois /week (0,6t/d) 1 month : 2 tubes 1 fois /week (0,3t/d)and for multibullous form attack with weigth > 45kg treatment 3 tubes of 10g (3t/d)decreasing treatment 1 month : 3 tubes every 2days (1,5t/d) 1 month : 3 tubes 2 fois /week (1t/j)1 mois : 3 tubes 1 fois /week (0,45t/d) | Drug | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
Related trials for Bullous Pemphigoid
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
RecruitingPhase 1
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Active, not recruitingObservational study
Association Between Disease Severity and Clinical, Histopathological, and Eosinophilic Markers in Patients With Bullous Pemphigoid (BP-EPIC)
Bullous Pemphigoid (BP)
Active, not recruitingPhase 3
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
Severe Forms of Mucous Membrane Pemphigoid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Joly, MD-PHD principal investigator
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.