PsoriasisNCT05144165
Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines
An observational study of Psoriasis and Psoriasis Palmaris, run by Centre of Evidence of the French Society of Dermatology at 1 site in France.
Trial summary
French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriasis Palmaris, Psoriasis Inverse
- What is being tested?
- Experts consensus
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2021to 31 Mar 2022
- 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: Members of the Centre of Evidence (M. Beylot-Barry, G. Chaby, O. Chosidow, F. Corgibet, L. Fardet, B. Guillot, N. Jouan, D. Jullien) will propose a list of 40 to 50 French dermatologists experts in the field of psoriasis. Members of the scientific committees of the psoriasis research group (French Society of Dermatology) and "Resopso" will be included in the list of experts, with the exception of those participating of the design and publication of the present study.
Who may be able to join
- French dermatologists
- public and private practice practitioners
- members of the French Society of Dermatology
- expertise in the field of psoriasis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Olivier CHOSIDOW, MD, PhD contact
Sophie LEDUCQ, MD contact
France1 site, 1 recruiting
- Recruiting
Center of Evidence of Dermatology
Paris, 75009
Olivier Chosidow, MD, PhD, olivier.chosidow@aphp.fr
Sophie Leducq, MD, sophie.leducq@univ-tours.fr
About this study
Official title: Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines Using Delphi Consensus Statement
French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Because several systemic treatments have been marketed since then, new guidelines are mandatory. The aim of this study coordinated by the Centre of Evidence of the French Society of Dermatology is to update the available French guidelines using a Delphi method.
Read the detailed description
Justification of Delphi methodology
The Delphi method has been widely used for elaboration of guidelines. The goal of the Delphi method is to solicit group opinion and to combine the opinion of a panel of experts into a consensus (or dissensus). During a Delphi study, multiple rounds of questionnaires are sent to a panel of experts with feedback between rounds, allowing experts to re-evaluate their responses along with the replies of other experts.
Design, expert eligibility and data collection A steering committee of members of the French Centre of Evidence (G. Chaby, F. Corgibet, L. Fardet, S. Leducq, F. Poizeau https://reco.sfdermato.org/fr/centre-de-preuves-en-dermatologie) and members of the Psoriasis Research Group of the French Society of Dermatology (M. Chastagner, L. Gouillon), without any competing interest regarding this topic, will be in charge with elaboration and conduction of the Delphi study.
The selected experts will be asked whether they agree to participate in the Delphi survey. Upon acceptance, they will be asked to answer the Delphi study administered using the online survey Welphi®. Before the first round, demographic information (age, sex, location of practice, availability of a phototherapy cabin, public or private practice) and competing interests will be collected. All experts will provide informed consent. Experts will have 2 weeks to complete the online survey with two email reminders. For each round, the number of experts who completed the surveys will be documented.
Procedure
Definition of consensus For statements with responses on an ordinal 7-point Likert scale (rating 1, strongly disagree to 7 strongly agree), 'agreement' will be defined as a score of 5-7, 'neutral' by a score of 4 and 'disagreement' by a score of 1-3. Consensus will be defined as achieved when > 70% experts will vote for a given option on the Likert scale. For Multiple Choice Questions (MCQs), consensus will be defined as achieved if > 70% experts voted for a particular option. Median and interquartile range (IQR) will be used to describe the central tendency and dispersion of responses: a "strong statement" will be defined as a median score of ≥ 6 or ≤ 2 on the Likert scale and 90% votes for MCQs. If consensus is not reached for one question (using Likert scale or MCQ) after 3 rounds, dissensus is acted. For this study, four rounds are planned, including round 1 with open-ended questions (see below) and a maximum of three rounds to obtain consensus.
- Conditions
- Psoriasis, Psoriasis Palmaris, Psoriasis Inverse, Psoriasis Vulgaris, Psoriatic Nail, Psoriatic Plaque
- Being tested
- Experts consensus
- Keywords
- Delphi, Consensus statement, Guidelines, Experts
- Medical subject headings
- Psoriasis, Guttate Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experts consensusOther
Consensus opinion using Delphi Methodology
What is being measured
The primary outcome is the main question the study is designed to answer.
Update of the French guidelines by consensus using participating experts opinions
Round 1 will include
- 3 questions using an ordinal 7-point Likert scale, regarding every systemic treatment that could be prescribed as a first, second or subsequent line, in patients with moderate-to-severe plaque psoriasis without contra-indication to any treatment
- 9 questions using an ordinal 7-point Likert scale, regarding first line therapeutic management of particular forms of psoriasis
- 11 open-ended questions for special indications of each therapeutic agent.
Round 2, 3 and 4 Experts will be asked to review the questionnaire based on the information provided in the former round. They will have to re-rate the 12 questions using the 7-point Likert scales. Regarding special indications for each therapeutic agent, expert's comments from round 1 will be synthesized and converted into MCQs for subsequent rounds. If consensus is reached for one question, the question will not reappear in subsequent rounds.
Measured: 15 days to complete the online survey for each round
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start8 Nov 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Evidence of the French Society of Dermatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144165
- Sponsor's protocol ID
- CDPDelphiPso
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.
PubMed 30793796
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines Using Delphi Consensus Statement
- ClinicalTrials.gov ID
- NCT05144165
- Acronym / sponsor ID
- CDPDelphiPso
- Conditions
- Psoriasis, Psoriasis Palmaris, Psoriasis Inverse, Psoriasis Vulgaris, Psoriatic Nail, Psoriatic Plaque
- Keywords
- Delphi, Consensus statement, Guidelines, Experts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre of Evidence of the French Society of DermatologyUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 3 Dec 2021 (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.
French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Because several systemic treatments have been marketed since then, new guidelines are mandatory. The aim of this study coordinated by the Centre of Evidence of the French Society of Dermatology is to update the available French guidelines using a Delphi method.
Detailed description
Justification of Delphi methodology
The Delphi method has been widely used for elaboration of guidelines. The goal of the Delphi method is to solicit group opinion and to combine the opinion of a panel of experts into a consensus (or dissensus). During a Delphi study, multiple rounds of questionnaires are sent to a panel of experts with feedback between rounds, allowing experts to re-evaluate their responses along with the replies of other experts.
Design, expert eligibility and data collection A steering committee of members of the French Centre of Evidence (G. Chaby, F. Corgibet, L. Fardet, S. Leducq, F. Poizeau https://reco.sfdermato.org/fr/centre-de-preuves-en-dermatologie) and members of the Psoriasis Research Group of the French Society of Dermatology (M. Chastagner, L. Gouillon), without any competing interest regarding this topic, will be in charge with elaboration and conduction of the Delphi study.
The selected experts will be asked whether they agree to participate in the Delphi survey. Upon acceptance, they will be asked to answer the Delphi study administered using the online survey Welphi®. Before the first round, demographic information (age, sex, location of practice, availability of a phototherapy cabin, public or private practice) and competing interests will be collected. All experts will provide informed consent. Experts will have 2 weeks to complete the online survey with two email reminders. For each round, the number of experts who completed the surveys will be documented.
Procedure
Definition of consensus For statements with responses on an ordinal 7-point Likert scale (rating 1, strongly disagree to 7 strongly agree), 'agreement' will be defined as a score of 5-7, 'neutral' by a score of 4 and 'disagreement' by a score of 1-3. Consensus will be defined as achieved when > 70% experts will vote for a given option on the Likert scale. For Multiple Choice Questions (MCQs), consensus will be defined as achieved if > 70% experts voted for a particular option. Median and interquartile range (IQR) will be used to describe the central tendency and dispersion of responses: a "strong statement" will be defined as a median score of ≥ 6 or ≤ 2 on the Likert scale and 90% votes for MCQs. If consensus is not reached for one question (using Likert scale or MCQ) after 3 rounds, dissensus is acted. For this study, four rounds are planned, including round 1 with open-ended questions (see below) and a maximum of three rounds to obtain consensus.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the Centre of Evidence (M. Beylot-Barry, G. Chaby, O. Chosidow, F. Corgibet, L. Fardet, B. Guillot, N. Jouan, D. Jullien) will propose a list of 40 to 50 French dermatologists experts in the field of psoriasis. Members of the scientific committees of the psoriasis research group (French Society of Dermatology) and "Resopso" will be included in the list of experts, with the exception of those participating of the design and publication of the present study.
Key inclusion criteria (4 listed)
- French dermatologists
- public and private practice practitioners
- members of the French Society of Dermatology
- expertise in the field of psoriasis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Experts consensusConsensus opinion using Delphi Methodology | Other | – |
Primary outcome
Update of the French guidelines by consensus using participating experts opinions
Time frame: 15 days to complete the online survey for each round
Round 1 will include * 3 questions using an ordinal 7-point Likert scale, regarding every systemic treatment that could be prescribed as a first, second or subsequent line, in patients with moderate-to-severe plaque psoriasis without contra-indication to any treatment * 9 questions using an ordinal 7-point Likert scale, regarding first line therapeutic management of particular forms of psoriasis * 11 open-ended questions for special indications of each therapeutic agent. Round 2, 3 and 4 Experts will be asked to review the questionnaire based on the information provided in the former round. They will have to re-rate the 12 questions using the 7-point Likert scales. Regarding special indications for each therapeutic agent, expert's comments from round 1 will be synthesized and converted into MCQs for subsequent rounds. If consensus is reached for one question, the question will not reappear in subsequent rounds.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Results publication: PubMed 30793796Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Societe Francaise de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.
- French Centre of Evidence in DermatologyLink provided by the sponsor.
- 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.
Olivier CHOSIDOW, MD, PhD contact
Sophie LEDUCQ, MD contact
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 Psoriasis and Psoriasis Palmaris, run by Centre of Evidence of the French Society of Dermatology 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 4 inclusion and 0 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 3 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier CHOSIDOW, MD, PhD (olivier.chosidow@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Update of the French guidelines by consensus using participating experts opinions (time frame: 15 days to complete the online survey for each round). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144165, which also lists 1 linked publication.
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 3 Dec 2021.