Tolcylen
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Product Description
Tolcylen™ Antifungal/Nail Renewal Solution was developed initially to be marketed as a prescription drug. After 3 years of research and testing by leading pharmacological scientist, it was launched in early 2017 as an OTC physician only dispensed product. Marlinz Pharma has multiple patents pending on the specialized processes and formulations required to create a product capable of changing the paradigm for treating fungal and non-fungal skin and nail disease symptoms. Tolcylen™ Solution is a first product of any kind that can deliver a low molecular weight, low surface tension anti-fungal formulation to infection sites while also introducing cosmetic agents clinically proven to rapidly improve the appearance of thickened, dehydrated and discolored nails.
Tolcylen™ Solution is the only OTC product utilizing an alcohol excipient formulation similar to topical prescription products which have been scientifically proven and FDA approved to penetrate and carry anti-fungal agents through the nail plate. As a comparison, most OTC topical antifungal products sold through physicians in the past utilize multiple seed oils as base excipients. While inexpensive to use and easy to mix, these seed oils are high surface tension, high molecular weight excipients which have been shown to actually block absorption of anti-fungal agents.
Tolcylen™ Solution features emulsified tolnaftate in a solution form, providing both curative and preventive treatment to infection sites of the skin, including the cuticle, hyponychial and nail fold areas. Undecylenic acid is commonly utilized as an anti-fungal agent proven to kill fungal infections. Our proprietary formulation utilizes undecylenic acid as a cleansing and emulsifying excipient able to lower the surface tension of the other agents it is emulsified with in solution. In a Cochrane database summary of 72 placebo controlled studies, undecylenic acid was the most effective topical drug for curing tinea pedis at 72%, while terbinafine was second at 70%, followed by tolnaftate at 64% and all azoles at 47%. Within this category undecylenic acid has the lowest molecular weight by a significant margin.
The cosmetic ingredients found in Tolcylen™ (including urea, lactic acid and propylene glycol) have been clinically shown to improve nail appearance of fungal and non-fungal nails beginning as early as 10 days. Several placebo controlled studies show 92% of patients with onychomycosis see marked improvement in nail appearance within 8 weeks and 77% at 2 weeks respectively, when treated with a formulation containing these cosmetic agents.
A separate study of 485 onychomycosis patients showed treatment using the same cosmetic ingredients for a 24 week period, resulted in a 27% mycological and clinical cure rate even though no anti-fungal agent was present. This anti-fungal activity from cosmetic agents is thought to be achieved by penetrating the nail plate with low weight; low surface tension agents that dynamically change the pH range fungi need to survive. The FDA approved prescription topical anti-fungal drugs’ mycological and clinical combined cure rates range from 5% to 16% at 48 to 52 weeks due primarily to very low clinical improvement rates.
By combining antifungal, cosmetic and low molecular weight agents, Tolcylen™ Solution is the only product of any kind to simultaneously treat fungal infections and nail appearance in one formulation. Feedback from accounts dispensing Tolcylen™ Solution for up to a year has been overwhelmingly positive with many reporting 90%+ patient satisfaction at 1 to 3 months.
Tolcylen™ Solution is package in a 7.5ml soft tube with a specialized screw on cap to prevent leakage and evaporation. The patented delivery system features a brush tip applicator for ease of use and enhanced saturation of the cuticle, hyponychial, nail and nail fold areas.
