Clinical Research Directory

Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis

This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution. The efficacy objectives of the study will be assessed using fungal culture testing, Neutral Red Staining (NRS) microscopy examination, and KOH microscopy examination after 4 weeks of treatment with VTR-297.

A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails

Onychomycosis is a fungal infection of the toenail caused by a range of organisms, including dermophytes, non-dermophyte molds, and yeasts. Topical antifungals are often used for mild to moderate onychomycosis, especially when oral therapy is contraindicated. Generally, topical antifungal agents are well-tolerated with minimal side effects, but they are less effective than oral antifungal therapies due to poor nail penetration. Consequently, the current treatment period for topical onychomycosis products is \~12 months. Terbinafine is an antifungal drug approved by the FDA for the treatment of topical skin infections. A new formulation (AP4500) has been developed to increase terbinafine absorption through the nail in order to directly kill fungi at the site of onychomycosis infection. The goal of this clinical trial is to learn if AP4500 works to treat mild to moderate toenail fungus in adults. The main questions the study aims to answer are: Does AP4500 work to treat onychomycosis? Does AP4500 work best when applied once or twice per day? Does AP4500 treat onychomycosis faster than current treatments? Is AP4500 more effective than current treatments? Researchers will compare AP4500 to a vehicle control (a look-alike substance that contains no drug) and a commercial comparator product (Jublia) that has already been commercialized for the treatment of toenail fungus. Participants will: Apply topical formulations once or twice a day to an infected toenail for a period of 48 weeks Visit the clinic 4 times over this period for checkups and tests, with a subsequent follow up visit 4 weeks after treatment is completed

Photodynamic Therapy and Topical Antifungal for Onychomycosis in Patients With Diabetes.

There are different therapeutic alternatives for onychomycosis. Systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than five drugs is not recommended even though these individuals are at serious risk of fungal infection. On the other hand, laser therapy would be contraindicated in patients with neuropathy or peripheral vascular disease (diabetic foot patients) because of possible burns. Topical antifungals or lacquers are associated with a low risk of systemic adverse events and drug-drug interactions and would therefore be the most appropriate treatment for patients with diabetic foot. However, they require very long treatment periods, are generally applied daily for 12 months to allow the normal nail to grow and replace the regions damaged by the infection and have a lower cure rate. Because of all the above difficulties, there is a need to augment topical treatments in routine clinical practice with adjunctive therapies such as photodynamic therapy for the treatment of onychomycosis in patients with diabetes. The main aim of this study is to observe the effectiveness and safety of the combination of photodynamic therapy with the usual antifungal treatment in consultation in patients with diabetes. Secondary aims have been defined as follows: To determine whether 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis; And to analyse the influence of the type of onychomycosis (ODL, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (through the OSI) on the response to treatment. Patients included in the study will be visited every 2 weeks during the first two months, applying photodynamic therapy during visits 2, 3 and 4. Subsequently, a check-up will be performed two weeks after the last application of photodynamic therapy and monthly visits for the remainder of the study. At each visit and at subsequent check-ups, the nail plate and peri- and subungual hyperkeratotic tissue will be debrided and reamed in order to improve the effects of the treatment.

Topical Application of Essential Oils to Treat Onchomycosis

Patients with documented onychomycosis of one or more toe nails will be treated with a daily application of a topical lacquer containing several essential oils.

Safety and Efficacy of Next Science Gel on Toenail Fungus

This is a 52 week, 20-patient open-label pilot study on the safety and efficacy of Next Science Wound gel in the treatment of mild to moderate Distal Subungual Onychomycosis.