Active topical nail solution versus placebo for the treatment of pedal onychomycosis

Phase 2

• Conditions: Onychomycosis (tinea unguium) localized to toenails; Infections and Infestations

• Registration Number: ISRCTN77852934
• Lead Sponsor: Marlinz Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-27
• Last Update Posted: 26 August 2024
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Male or female participants aged 18 years or older
2. If female is of childbearing potential, she must not be pregnant at the time of enrollment and she must be using an accepted form of birth control during the study treatment period (acceptable forms include: post-menopausal, surgical sterility, complete abstinence, sterilized sexual partner, tubal occlusion, copper-T intrauterine device, levonorgestrel-releasing intrauterine device, medroxyprogesterone injections, etonogestrel implants, combined pills, norelgestromin/ethinyl estradiol transdermal system, intravaginal device, or Cerazette pill; and for males the use of a condom with spermicide or surgical sterility)
3. Participant has a diagnosis of onychomycosis diagnosed by means of history, physical examination, and positive (evidence of fungal hyphae) mycological tissue examination by periodic acid-Schiff (PAS) staining
4. At least one toenail with distal subungual involvement, localized to any toe, with at least 10% involvement and including up to 100% involvement of the visible nail plate, any nail plate thickness, with the index nail being the most involved per inspection by the on-site investigator and agreed upon by the designated co-investigator study doctor (Hye Kim, DPM), who will inspect specific clinical photographs of the involved nail/s (the photographs will be obtained at each study site using a specified method, as demonstrated to site investigators, so that the clinical features are appropriately demonstrated)
5. Participant has an intact protective cutaneous sensation as measured with the Ipswich test for loss of protective sensation (10-gram monofilament)
6. Participant has an intact cutaneous barrier, with or without the presence of hyperkeratotic lesions, with or without concomitant tinea pedis or interdigital maceration, or with or without a history of previous skin ulceration, but without active or current pedal ulceration
7. Participant must be a satisfactory candidate for the proposed topical antifungal or placebo intervention
8. Participant must display the ability to understand and give informed consent to participation, on a voluntary basis, in the research study

Exclusion Criteria

1. Presence of dermatophytoma, defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed
2. Use of any systemic antifungal therapeutic agents within 7 months before the baseline visit, or topical antifungal agent on the feet within 1 month preceding the baseline measurement visit
3. Candidate with moccasin tinea pedis involving greater than 50% of either plantar surface
4. Candidate requires the use of narcotic analgesic or non-steroidal anti-inflammatory drug/s for 48 hours prior to baseline visit or at any follow-up clinical evaluations
5. Candidate has an active drug/alcohol dependence or abuse history
6. Candidate has a loss of protective pedal sensation or open cutaneous compromise involving the ipsilateral foot
7. Candidate has trauma to the nail that resulting in permanent nail plate discoloration or shape
8. Candidate displays radiographic evidence of abnormal lytic or proliferative bone lesion in the toe/s of interest, including recent or healing of an acute fracture, if clinical inspection indicates the potential presence of subungual exostosis (radiographs will be obtained and paid for in the course of usual and customary care, outside of participation in this study)
9. Candidate has had previous nail matrix ablative surgery, either chemical or cold steel, on any of the involved digits
10. Candidate presents systemic or local contraindications to the proposed application of the topical antifungal nail solution or the placebo agent, such as an uncontrolled cardiac, neurological, hepatic, renal, metabolic, or hematological disease or impairment that has been identified
11. Candidate suffers from malignant, or bacterial or viral infectious cause/s of nail plate dystrophy
12. Candidate shows signs of substantial peripheral circulatory insufficiency
13. Candidate is currently participating in another surgical, device, or drug study or has participated in any research study involving an investigational device or drug, or surgical procedure, within the preceding 30 days
14. Candidate is allergic to any of the study products
15. Candidate is unwilling or unable to comply with the study procedures
16. Candidate is affiliated with the investigator or persons working at a study site, or patient who is an employee of the sponsor’s company
17. Candidate is institutionalized because of legal or regulatory order
18. Candidate is unable to provide informed consent to voluntarily participate in clinical research.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mycological presence or absence of fungal hyphae detected using Periodic Acid-Schiff (PAS) stain of toenail fragments at baseline, 3, 7 and 9 months

Secondary Outcome Measures

Name	Time	Method
1. Quality of life measured using ONYCOE-t™ quality of life outcome score at baseline, 3, 7 and 9 months<br>2. Clinical appearance of an involved toenail assessed using the Visible Nail Plate Involvement Score at baseline, 3, 7 and 9 months