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.
