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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04644523
Other study ID # APHP200701
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date May 15, 2021

Study information

Verified date July 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - age < 18 years - Presence of unilateral RP where the capillaroscopy is normal regardless of the cause

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dermoscopy
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.

Locations

Country Name City State
France Hôpital de Tenon Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dermoscopic items To determine wich dermoscopic items predict normal capillaroscopy in a first-time attending RP. November 2022
Secondary Photography Reproducibility of dermoscopy for the 5 items: all photographs of dermoscopy will be reviewed by another investigator from another center. November 2022
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