PHARMACY Program
Onychomycosis is among the most persistent nail conditions, often protected by biofilm that topical treatments cannot reach. The Duo-Step Nail Program addresses infection in two steps: a compounded cleansing formula to break down debris, followed by a TargetedRx suspension to treat the underlying pathogens.
Evidence suggests the abnormally difficult-to-treat nature of onychomycosis may be caused by the formation of biofilms. To address the possible role of biofilms in onychomycosis, anti-biofilm treatment is suggested in combination with traditional antifungals.
With the rise in predisposing factors, it is important to prevent early and address treatment with continued investigation into anti-biofilm therapy including optimal treatment combinations and dosages targeted specifically to dermatophytes.
1000X
Once a mature bacterial biofilm is established, the high antibiotic dosage necessary for effective treatment can be inhibitory as a decreased susceptibility of up to 1000 fold has been documented.
Gupta, AK et al. The Role of Biofilms in Onychomycosis. J Am Acad Dermatology 2016; 74:1241-6.
8816
A total of 8816 clinically suspicious toenail samples were collected by podiatric physicians across the United States. PCR-generation sequencing and quantitative PCR were used to identify and quantify dermatophytes, non-dermatophyte molds, and bacteria.
50%
Approximately 50% of suspicious toenails contained both fungi and bacteria with the dermatophyte Trichophyton rubrum contributing the highest relative abundance and presence in 40% of these samples.
34%
Of the remaining samples, 34% had bacterial species present.
Annetto, et al. Fungal Diversity and Onychomycosis. J Am Podiatr Med Assoc 2019; 109(1): 57–63.
<1%
Fungi only were present in less than 1% of samples.
The Duo-Step Nail Program is designed to address the biofilm barrier that makes nail infections so difficult to treat.
The program works by:
The Duo-Step Nail Program offered at Customedico Pharmacy + Wellness is a comprehensive, on-going initiative to remove and prevent biofilms, treat an infection with a topical TargetedRx, and restore any imbalance to the microenvironment.
Spray and massage compounded prescription cleansing formula to penetrate and break down debris to prep for treatment step.
After cleansing, apply TargetedRx compounded prescription suspension to nail and surrounding nailbed to treat pathogens identified in the underlying nail infection.
Follow these instructions at each application to get the most from your Duo-Step Nail Program.
Step
One
Apply Ibuprofen 0.1% Compounded Cleansing Oil as first step of Duo-Step program prior to anti-infective TARGETED RX suspension therapy.
Step
Two
After cleansing, apply the anti-infective compounded TARGETED RX suspension as second step of Duo-Step program to clear the nail infection.
DuoStep Nail Program
Comparison
Jublia®
Prior authorization
Affordability
Application
Duration
Side effects**
DuoStep Nail Program
Comparison
Itraconazole oral / Terbinafine oral
Application
Duration
Side effects**
Interactions**
*Source: pharmacy patient outcomes data **Source: Jublia / Itraconazole / Terbinafine Package Insert
Apply a compounded topical prescription directly to the affected nail as directed by your provider as part of the DuoStep Nail Program to:
Oral terbinafine, the current gold standard for onychomycosis, achieves mycological cure in only 35–50% of patients — meaning the majority of patients fail first-line therapy even when treatment is completed as prescribed. Biofilm-mediated resistance is a key driver of this treatment gap, as standard systemic therapy cannot adequately penetrate the nail bed biofilm to reach the infecting organisms.
Gupta AK, Stec N. Recent advances in therapies for onychomycosis and its management. F1000Res. 2019;8:F1000 Faculty Rev-968.
In a controlled trial, combination topical therapy pairing an anti-biofilm penetrant with an antifungal achieved complete cure in 55% of patients, compared to just 13% with antifungal therapy alone — a more than 4-fold improvement. Disrupting the biofilm matrix first allowed the antifungal to reach and eliminate the organisms protected within the nail bed structure.
Syed TA, et al. Management of toenail onychomycosis with 2% butenafine and 20% urea cream: a placebo-controlled, double-blind study. J Dermatol. 1998;25(10):648–652.
Customicro Clinical Services is partnered with Customedico Pharmacy + Wellness, an independently owned compounding pharmacy dedicated to the provision of personalized medications to meet the unique needs of our patients.
Reach out to learn how Customicro Clinical Services can support your patients.
10900 N. Scottsdale Rd #403, Scottsdale, AZ 85254
480-946-1345
