A Phase II, Randomized, Double-blind, Vehicle-controlled Study to Investigate the Efficacy, Safety, and Tolerability of HXP124 in Patients with Mild to Moderate Onychomycosis.

Hexima Ltd0 sites117 target enrollmentJune 23, 2020

ConditionsToenail Onychomycosis Infection - Other infectious diseases Skin - Dermatological conditions

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Toenail Onychomycosis
Sponsor: Hexima Ltd
Enrollment: 117
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 23, 2020

End Date

May 9, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hexima Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Presence of mild to moderate clinically diagnosed DLSO, defined as involving at least 20% but not more than 60% nail plate involvement of at least one great toenail as determined by visual inspection at screening after the nail has been trimmed;
•2\. Confirmed diagnosis of onychomycosis by positive mycological microscopic examination (staining by potassium hydroxide (KOH) for dermatophyte hyphae) and positive dermatophyte culture or a mixed culture of dermatophytes/Candida from the target great toenail at screening;
•Note: It is known that both cultures and stains may yield false negative results. If the stain
•exhibits fungal elements or septate hyphae but the culture fails to grow a fungus, the culture may be repeated. If the culture grows but the stain does not exhibit fungal elements or septate hyphae, the stain may be repeated. If two sequential cultures or two subsequent stains are negative, the nail should not be included in the study.
•3\. The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is less than or equal to 3 mm at screening;
•4\. A clear nail distance of less than or equal to 3 mm from the proximal nail fold at screening;
•5\. Males and females aged 18\-70 years (inclusive) in otherwise good health based on past
•medical history, physical examination, vital signs, ECG, and laboratory tests at screening, as determined by the PI;
•Note: Participants with Type 2 diabetes mellitus (T2DM) under glycemic control who
•manage their condition only by diet/exercise will be considered for study participation, at the discretion of the PI.

Exclusion Criteria

•Exclusion Criteria
•1\.Presence of dermatophytoma in the target great toenail;
•2\.Lunula (matrix) involvement or exclusively lateral disease in the target great toenail;
•3\.Presence of hyperkeratotic/moccasin\-type tinea pedis (athletes’ foot) at screening or baseline visits;
•4\.Presence of toenail infection other than being caused by dermatophytes and Candida;
•5\.Previous toenail surgery of the target great toenail;
•6\.Presence of more than 6 infected toenails and/or any infected fingernails;
•7\.Presence of any disease or condition other than DLSO that might cause nail abnormalities or interfere with the evaluation of the study drug;
•8\.Pregnant or lactating female at screening or plans to become pregnant or breastfeed from the time of enrolment until 30 days after the last application of study drug;
•9\.Use of any systemic antifungal therapy with known activity against dermatophytes within 12 weeks prior to the Screening visit part 1;