Bullous PemphigoidPRURIPBNCT03272958
Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
An observational study of Bullous Pemphigoid, run by University Hospital, Brest at 16 sites in France.
Trial summary
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied. The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- How many people
- 63 participants
- Where
- 16 sitesFrance
- Study dates
- 7 Nov 2017to 3 Oct 2018
- 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: All patients with a new diagnosis of bullous pemphigoid
Who may be able to join
- adult
- pruriginous bullous pemphigoid lately diagnosed.
- Without PB treatment
- MMS (Mini Mental State Examination) ≥ 21
- In hospitalization or consultation
Who cannot join
- pregnant woman
- nursing women
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CH Argenteuil
Argenteuil, 95100
AP-HP, Hôpital Avicenne
Bobigny, 93009
CHU de Bordeaux
Bordeaux, 33404
CHRU de Brest
Brest, 29609
CHU Caen
Caen, 14033
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
AP-HP, Hôpital Henri Mondor
Créteil, 94000
CHU Le Havre
Le Havre, 76083
HP-HM
Marseille, 13385
CHU de Montpellier
Montpellier, 34295
CH de Niort
Niort, 79021
AP-HP, Hôpital Cochin
Paris, 75006
AP-HP, Hôpital Bichat
Paris, 75018
CHU de Reims
Reims, 51092
CHU de Rouen
Rouen, 76031
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.
The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.
- Conditions
- Bullous Pemphigoid
- Keywords
- Pruritus, Bullous pemphigoid
- Medical subject headings
- Pemphigoid, Bullous, Pruritus
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of pruritus in patients with bullous pemphigoid
Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid
Measured: Day1 ( when diagnosis of bullous pemphigoid is made)
Secondary outcomes (3)
Impact of pruritus on quality of life in patients with bullous pemphigoid
Score 5D itch scale
Measured: Day 1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
score ItchyQol (Itchy Quality of Life)
Measured: Day1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
score ABQOL
Measured: Day 1 (when diagnosis of bullous pemphigoid is made )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start7 Nov 2017
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
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, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272958
- Sponsor's protocol ID
- 29BRC17.0066 ( PRURIPB)
- Acronym
- PRURIPB
- Status last verified
- Jan 2019
- First submitted
- 21 Jul 2017
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT03272958
- Acronym / sponsor ID
- PRURIPB / 29BRC17.0066 ( PRURIPB)
- Conditions
- Bullous Pemphigoid
- Keywords
- Pruritus, Bullous pemphigoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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.
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.
The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a new diagnosis of bullous pemphigoid
Key inclusion criteria (5 listed)
- adult
- pruriginous bullous pemphigoid lately diagnosed.
- Without PB treatment
- MMS (Mini Mental State Examination) ≥ 21
- In hospitalization or consultation
Key exclusion criteria (2 listed)
- pregnant woman
- nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical characteristics of pruritus in patients with bullous pemphigoid
Time frame: Day1 ( when diagnosis of bullous pemphigoid is made)
Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid
3 secondary outcomes
Impact of pruritus on quality of life in patients with bullous pemphigoid
Time frame: Day 1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
Time frame: Day1 (when diagnosis of bullous pemphigoid is made )
Impact of pruritus on quality of life in patients with bullous pemphigoid
Time frame: Day 1 (when diagnosis of bullous pemphigoid is made )
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 7 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites 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, Brest at 16 sites 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 5 inclusion and 2 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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.
What does the primary outcome measure?
Clinical characteristics of pruritus in patients with bullous pemphigoid (time frame: Day1 ( when diagnosis of bullous pemphigoid is made)). It is what the study was designed to measure, not a finding.
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 7 Jan 2019.