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RECRUITING
NCT07828184
NA

URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis

Sponsor: CEN Biotech

View on ClinicalTrials.gov

Summary

The objective of this clinical study is to evaluate the performance of URGO MICKAEL Filmogel as a topical treatment for mild to moderate onychomycosis

Official title: PERFORMANCE AND SAFETY OF THE MEDICAL DEVICE "URGO ONGLES ABIMES PAR MYCOSES ET TRAUMATISMES" IN THE TREATMENT OF MILD TO MODERATE DISTAL ONYCHOMYCOSIS: AN OPEN STUDY (MICKAEL)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-01-28

Completion Date

2027-06-30

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DEVICE

URGO MICKAEL Filmogel

The device is used daily on 1 or 2 big toenails for up to 6 months The investigator may decide to discontinue treatment at after 1 or 3 months if the studied toenail(s) meet all the following criteria: 1. Negative dermatophyte/fungal culture. 2. Healthy appearance of the studied toenail(s), defined by a score of 0 ("none") for all the following items: onycholysis, nail dystrophy, nail discoloration, and nail thickening.

Locations (1)

Cen Experimental

Dijon, France