Raynaud PhenomenonVASCUL-RNCT04644523
Dermoscopy in Primary Raynaud's Phenomenon
An observational study of Raynaud Phenomenon, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Raynaud Phenomenon
- What is being tested?
- Dermoscopy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 15 May 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Patients with Raynaud's phenomenon requiring capillaroscopy
Who may be able to join
- age > 18 years
- first consultation for bilateral Raynaud's phenomenon (RP)
- Bilateral Raynaud's phenomenon affecting at least one finger of each hand defined by a paroxysmal syncopal phase on exposure to cold,
- Affiliated to the French health care systeme
Who cannot join
- age < 18 years
- Presence of unilateral RP where the capillaroscopy is normal regardless of the cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Validation of 5 Items in Nailfold Dermoscopy to Predict a Normal Capillaroscopy in Raynaud's Phenomenon
Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study has evaluated the performance of dermoscopy in primary RP. The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.
Read the detailed description
Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study evaluated the performance of dermoscopy in primary RP. A preliminary study (Tenon Hospital) showed an interest of dermoscopy in primary and secondary RP, with a negative predictive value of dermoscopy of 100% for capillaroscopy.
This is a prospective, multicentric French study comparing dermoscopy and capillaroscopy in patients attending dermatology or vascular medicine departments for the first evaluation of a RP.
The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.
The main hypothesis is that a normal dermocopy on five items is highly predictive of a normal NFC.
During a first consultation for RP, NFC will be realized with a clinical exam and a biological test (antinuclear antibodies), as official recommendations. Dermoscopy of peri-ungueal area will be realized by another investigator, if possible during the same consultation. Photographs of all fingers, except thumbs, will be made and will be reviewed by another investigator of another center. There will be no follow-up.
- Conditions
- Raynaud Phenomenon
- Being tested
- Dermoscopy
- Keywords
- Dermoscopy, Nailfold capillaroscopy
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermoscopyOther
dermoscopy is currently used in daily practice in dermatology, for melanoma screening. Dermoscopy will be used in this study on peri-ungueal area.
This is a non-invasive and painless exam.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermoscopic items
To determine wich dermoscopic items predict normal capillaroscopy in a first-time attending RP.
Measured: November 2022
Secondary outcomes (1)
Photography
Reproducibility of dermoscopy for the 5 items: all photographs of dermoscopy will be reviewed by another investigator from another center.
Measured: November 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jan 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud PhenomenonStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
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
- NCT04644523
- Sponsor's protocol ID
- APHP200701
- Acronym
- VASCUL-R
- Status last verified
- Jul 2021
- First submitted
- 21 Oct 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of 5 Items in Nailfold Dermoscopy to Predict a Normal Capillaroscopy in Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT04644523
- Acronym / sponsor ID
- VASCUL-R / APHP200701
- Conditions
- Raynaud Phenomenon
- Keywords
- Dermoscopy, Nailfold capillaroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 25 Nov 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.
Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study has evaluated the performance of dermoscopy in primary RP. The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.
Detailed description
Raynaud's phenomenon (RP) is very frequent in general population (up to 10%). Nailfold capillaroscopy (NFC) is recommended for patients presenting RP, to eliminate systemic disease such as systemic sclerosis. NFC is not easily available in clinical practice. Dermoscopy, used for pigmentary skin lesion screening, may help to detect giant loops, hemorrhages or other capillaries anomalies. However, no study evaluated the performance of dermoscopy in primary RP. A preliminary study (Tenon Hospital) showed an interest of dermoscopy in primary and secondary RP, with a negative predictive value of dermoscopy of 100% for capillaroscopy.
This is a prospective, multicentric French study comparing dermoscopy and capillaroscopy in patients attending dermatology or vascular medicine departments for the first evaluation of a RP.
The objective is to determinate which items in dermoscopy are correlated with a normal NFC and predict with a good negative predictive value, a normal NFC in RP patients. The secondary objective is to assess inter-observer reproducibility of dermoscopy in patients with RP.
The main hypothesis is that a normal dermocopy on five items is highly predictive of a normal NFC.
During a first consultation for RP, NFC will be realized with a clinical exam and a biological test (antinuclear antibodies), as official recommendations. Dermoscopy of peri-ungueal area will be realized by another investigator, if possible during the same consultation. Photographs of all fingers, except thumbs, will be made and will be reviewed by another investigator of another center. There will be no follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Raynaud's phenomenon requiring capillaroscopy
Key inclusion criteria (4 listed)
- age > 18 years
- first consultation for bilateral Raynaud's phenomenon (RP)
- Bilateral Raynaud's phenomenon affecting at least one finger of each hand defined by a paroxysmal syncopal phase on exposure to cold,
- Affiliated to the French health care systeme
Key exclusion criteria (2 listed)
- age < 18 years
- Presence of unilateral RP where the capillaroscopy is normal regardless of the cause
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 |
|---|---|---|
| Dermoscopydermoscopy is currently used in daily practice in dermatology, for melanoma screening. Dermoscopy will be used in this study on peri-ungueal area. This is a non-invasive and painless exam. | Other | – |
Primary outcome
Dermoscopic items
Time frame: November 2022
To determine wich dermoscopic items predict normal capillaroscopy in a first-time attending RP.
1 secondary outcome
Photography
Time frame: November 2022
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 20 Jul 2021.
- Individual participant dataSharing planned: No
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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.
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 Raynaud Phenomenon, run by Assistance Publique - Hôpitaux de Paris 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 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 20 Jul 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?
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?
Dermoscopic items (time frame: November 2022). 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 20 Jul 2021.