NCT06689852

Brief Summary

The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 3, 2025

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 13, 2024

Last Update Submit

September 2, 2025

Conditions

Onychomycosis

Keywords

onychomycosis

Outcome Measures

Primary Outcomes (1)

  • Blinded evaluation of the percentage of healthy nail surface

    Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail.

    270 days

Secondary Outcomes (7)

  • Percentage of healthy surface (performance)

    90 days, 180 days

  • Mirobiological efficacy ; KOH staining (Performance)

    270 days

  • Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance)

    90 days, 180 days, 270 days

  • Clinical efficacy: onychomycosis evolution (Performance)

    90 days, 180 days, 270 days

  • Impact on quality of life (Performance)

    180 days, 270 days

  • +2 more secondary outcomes

Study Arms (2)

Enriched

EXPERIMENTAL

To be used twice daily during 9 month

Device: Enriched

Loceryl

EXPERIMENTAL

To be used 1 per week during 9 months

Drug: Loceryl 5%

Interventions

EnrichedDEVICE

To be used twice a day

Enriched
Loceryl 5%DRUG

To be used once a week

Loceryl

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablets).
  • \. Patient with positive KOH staining. 6. Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
  • \. Patient being psychologically able to understand information and to give their/his/her consent.
  • \. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening.
  • \. Patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration.
  • \. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.

You may not qualify if:

  • \. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, France, 69100, France

RECRUITING

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Manon Laune, Project manager

CONTACT

+33472823656manon.laune@cpt.eurofinseu.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The primary objective is to evaluate the effectiveness of Enriched and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 15, 2024

Study Start

October 30, 2024

Primary Completion

July 4, 2025

Study Completion

April 1, 2026

Last Updated

September 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)