Prurigo NodularisPRURISEQNCT04681300
Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing
An observational study of Prurigo Nodularis and Atopic Dermatitis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Prurigo nodularis (PN) is a skin condition characterized by symmetrically distributed widespread, pruritic nodules that occurs in patients with chronic pruritus. There are 2 subtypes of PN depending on the association with an atopic dermatitis (AD) : atopic PN (Besnier) and non-atopic PN (Hyde). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis, Atopic Dermatitis
- What is being tested?
- Skin biopsy and Plastic surgery remnants
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to 15 Jul 2021
- 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
- Adult, Older adult
Study population: Adult patients with confirmed diagnosis of atopic dermatitis (n=5), atopic prurigo nodularis (of Besnier) (n=5) and non-atopic prurigo nodularis (of Hyde) (n=5) or from surgical residues of normal skin (n=5).
Who may be able to join
- More than 18 years of age
- Signature of the written contentment
- Clinical diagnostic of PN defined by the following: a minimum of 20 PN lesions, in total on both legs, and/or both arms; an average worst itch score of ≥7. Atopic PN will be defined as PN associating clinical sings or history of AD according to Hanifin et Rajka criteria. Non-Atopic PN will be defined as PN non-associated with clinical sings or history of AD according to Hanifin et Rajka criteria.
- or confirmed diagnosis of AD according to Hanifin et Rajka criteria without associated PN.
- Washout period for topical treatments (> 1 week) ans systemic treatments (> 1 month).
- Indication and absence of contraindication to performing a skin biopsy as part of the treatment
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- more than 18 years of age
- Signature of the written contentment
- Hospitalised in the plastic surgery department of Saint-Louis Hospital.
- No associated inflammatory or tumoral skin condition
- No contraindication for biopsy
Who cannot join
- Presence of inflammatory or tumoral skin morbidities other than PN and atopic dermatitis
- Treatment induced pruritus
- Pruritus secondary to other medical conditions such as bullous dermatosis, renal insufficiency, infectious diseases, …)
- AD under biologic therapy
- Patient under guardianship or conservatorship
- No health insurance coverage
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- Patient under State Medical Assistance (AME)
- Pregnancy or breastfeeding
- Persons deprived of their liberty by a judicial or administrative decision
- People undergoing psychiatric care making their consent impossible
- Adults who are the subject of a legal protection measure or unable to express their consent
- Patients unable to read and write
- Inflammatory or tumoral medical condition
- Biological therapy for any other medical condition
- Associated inflammatory or tumoral skin condition
- Pregnancy or breastfeeding
- Persons deprived of their liberty by a judicial or administrative decision
- People undergoing psychiatric care making their consent impossible
- Adults who are the subject of a legal protection measure or unable to express their consent
- Patients unable to read and write
Trial locations and contacts
No sites are listed yet.
About this study
Prurigo nodularis (PN) is a skin condition characterized by symmetrically distributed widespread, pruritic nodules that occurs in patients with chronic pruritus. There are 2 subtypes of PN depending on the association with an atopic dermatitis (AD) : atopic PN (Besnier) and non-atopic PN (Hyde). There are no approved therapies, and treatment options currently used have limited efficacy and their long-term use carries the risk of potential severe toxic effects.
The mechanisms triggering PN are still unknown. However, recent findings suggest a major role for the Th2 inflammatory pathway.
Beyond advancing the basic understanding of PN pathophysiology, our study might also pave the way for developing novel Th2-targeted therapeutic strategies for PN and AD. The primary objective of this study is to characterize the transcriptional profile of the T lymphocytes isolated from skin samples from patients with PN. This study will allow a gain a deeper understanding of the pathophysiologic mechanism of PN, a better classification of its subtypes, as well as their physiopathologic link with AD. Moreover, it will help shape new effective and safe therapeutic approaches in these diseases which are important for optimal therapeutic management.
- Conditions
- Prurigo Nodularis, Atopic Dermatitis
- Being tested
- Skin biopsy, Plastic surgery remnants
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyOther
a skin sample will be taken using a 4 mm punch biopsy in lesional skin
Plastic surgery remnantsOther
healthy skin from plastic surgery interventions
| Study group | Role | What they receive |
|---|---|---|
| Patients with atopic Prurigo nodularis , non-atopic Prurigo nodularis or atopic dermatitis | Not described Receives: Other: Skin biopsy | |
| Patients with plastic surgery interventions | Not described Receives: Other: Plastic surgery remnants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional profile of the T lymphocytes
Measured: at inclusion
Secondary outcomes (2)
Inflammatory pathways
Measured: at inclusion
Molecular differences
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study startFeb 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681300
- Sponsor's protocol ID
- APHP200325
- Acronym
- PRURISEQ
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing
- ClinicalTrials.gov ID
- NCT04681300
- Acronym / sponsor ID
- PRURISEQ / APHP200325
- Conditions
- Prurigo Nodularis, Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 23 Dec 2020 (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.
Prurigo nodularis (PN) is a skin condition characterized by symmetrically distributed widespread, pruritic nodules that occurs in patients with chronic pruritus. There are 2 subtypes of PN depending on the association with an atopic dermatitis (AD) : atopic PN (Besnier) and non-atopic PN (Hyde). There are no approved therapies, and treatment options currently used have limited efficacy and their long-term use carries the risk of potential severe toxic effects.
The mechanisms triggering PN are still unknown. However, recent findings suggest a major role for the Th2 inflammatory pathway.
Beyond advancing the basic understanding of PN pathophysiology, our study might also pave the way for developing novel Th2-targeted therapeutic strategies for PN and AD. The primary objective of this study is to characterize the transcriptional profile of the T lymphocytes isolated from skin samples from patients with PN. This study will allow a gain a deeper understanding of the pathophysiologic mechanism of PN, a better classification of its subtypes, as well as their physiopathologic link with AD. Moreover, it will help shape new effective and safe therapeutic approaches in these diseases which are important for optimal therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with atopic Prurigo nodularis , non-atopic Prurigo nodularis or atopic dermatitis | – | Other: Skin biopsy |
| Patients with plastic surgery interventions | – | Other: Plastic surgery remnants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with confirmed diagnosis of atopic dermatitis (n=5), atopic prurigo nodularis (of Besnier) (n=5) and non-atopic prurigo nodularis (of Hyde) (n=5) or from surgical residues of normal skin (n=5).
Key inclusion criteria (11 listed)
- More than 18 years of age
- Signature of the written contentment
- Clinical diagnostic of PN defined by the following: a minimum of 20 PN lesions, in total on both legs, and/or both arms; an average worst itch score of ≥7. Atopic PN will be defined as PN associating clinical sings or history of AD according to Hanifin et Rajka criteria. Non-Atopic PN will be defined as PN non-associated with clinical sings or history of AD according to Hanifin et Rajka criteria.
- or confirmed diagnosis of AD according to Hanifin et Rajka criteria without associated PN.
- Washout period for topical treatments (> 1 week) ans systemic treatments (> 1 month).
Key exclusion criteria (20 listed)
- Presence of inflammatory or tumoral skin morbidities other than PN and atopic dermatitis
- Treatment induced pruritus
- Pruritus secondary to other medical conditions such as bullous dermatosis, renal insufficiency, infectious diseases, …)
- AD under biologic therapy
- Patient under guardianship or conservatorship
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 |
|---|---|---|
| Skin biopsya skin sample will be taken using a 4 mm punch biopsy in lesional skin | Other | Patients with atopic Prurigo nodularis , non-atopic Prurigo nodularis or atopic dermatitis |
| Plastic surgery remnantshealthy skin from plastic surgery interventions | Other | Patients with plastic surgery interventions |
Primary outcome
Transcriptional profile of the T lymphocytes
Time frame: at inclusion
2 secondary outcomes
Inflammatory pathways
Time frame: at inclusion
Molecular differences
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prurigo Nodularis and Atopic Dermatitis, run by Assistance Publique - Hôpitaux de Paris.
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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-David BOUAZIZ (01 42 49 43 19, jean-david.bouaziz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional profile of the T lymphocytes (time frame: at inclusion). 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 9 Feb 2021.