Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

NCT03382717 | Completed

• 1 other identifier: 16E1078
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effect of the medical device "Excilor® Forte" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.

Conditions

Onychomycosis of Toenail

Outcome Measures

Primary Outcomes (1)

• Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail

  Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups

  After 30, 60, 120 and 180 days of treatment

Secondary Outcomes (5)

• Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.

  After 30, 60, 120 and 180 days of treatment

• Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.

  At baseline (day 0) and after 180 days of treatment

• Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.

  After 30, 60, 120 and 180 days of treatment

• Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.

  After 60 and 180 days of treatment

• Subject evaluation using an evaluation questionnaire, performed at each visit.

  After 30, 60, 120 and 180 days of treatment

Study Arms (2)

Excilor Forte

EXPERIMENTAL

One application of the MD daily (at same time point), preferably after showering/bathing, during the complete study period.

Device: Excilor Forte

Loceryl 5%

ACTIVE COMPARATOR

One application per week of the positive control Loceryl 5% during the whole study period.

Drug: Loceryl 5%

Interventions

Excilor Forte DEVICE

1 application per day during 6 months

Excilor Forte

Loceryl 5% DRUG

1 application per week during 6 months

Loceryl 5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject having given her/his informed, written consent.
• Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
• Subject being psychologically able to understand information and to give their/his/her consent.
• Age: more than 18 years.
• Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
• Subject with positive KOH staining.
• Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.

You may not qualify if:

• Subject considered by the Investigator likely to be non-compliant with the protocol.
• Patient enrolled in another clinical trial during the test period.
• · Woman being pregnant, nursing or planning a pregnancy during the course of this study.
• Subject having a known allergy to one of the constituents of the tested products.
• Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
• Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Sponsors & Collaborators

• Oystershell NV: lead

Study Sites (2)

Hospital Habib Thameur

Tunis, Tunisia

Location

Principal instruction military hospital

Tunis, Tunisia

Location

Related Publications (1)

• Eertmans F, Doss N, Rossel B, Adriaens E. Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial. Dermatol Ther (Heidelb). 2018 Sep;8(3):463-473. doi: 10.1007/s13555-018-0254-1. Epub 2018 Jul 26.

  PMID: 30051298 DERIVED

Study Officials

• Nejib Doss, MD

  Principal Instruction military hospital of Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 26, 2017
• Study Start: October 26, 2016
• Primary Completion: August 26, 2017
• Study Completion: August 26, 2017
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)