Dermoscopy in Primary Raynaud's Phenomenon

NCT04644523 | Completed

• 1 other identifier: APHP200701
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Raynaud Phenomenon

Keywords

Dermoscopy; Nailfold capillaroscopy

Outcome Measures

Primary Outcomes (1)

• Dermoscopic items

  To determine wich dermoscopic items predict normal capillaroscopy in a first-time attending RP.

  November 2022

Secondary Outcomes (1)

• Photography

  November 2022

Interventions

Dermoscopy OTHER

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Raynaud's phenomenon requiring capillaroscopy

You may qualify if:

• 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

You may not qualify if:

• age \< 18 years
• Presence of unilateral RP where the capillaroscopy is normal regardless of the cause

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital de Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Raynaud Disease

Interventions

Dermoscopy

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 25, 2020
• Study Start: January 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)