The Duo•Step nail program manages biofilm-based nail infections in two simple steps!
Why Target Biofilms?
Targeting biofilms is crucial for effective infection management due to their role in antibiotic resistance and persistent infections. Strategies to combat biofilms include breaking down the extracellular polymeric substance (EPS) matrix to enhance antibiotic effectiveness, inhibiting their initial formation, and utilizing specialized agents designed to eliminate biofilm-associated bacteria. Addressing biofilms directly not only improves patient outcomes but also helps curb the spread of antibiotic-resistant infections.
- Sarah Simmers, PharmD
Up to
1000x
Once a mature bacterial biofilm is established, the high antibiotic dosage necessary for effective treatment can be inhibitive as a decreased susceptibility of up to 1000 fold has been documented.
Gupta, AK et al. The Role of Biofilms in of samples Onychomycosis.
J Am Acad Dermatology 2016; 74:1241-6.
A total of 8816 clinically suspicious toenail samples were collected by podiatric physicians across the United States ... next-generation sequencing and quantitative PCR were used to identify and quantify dermatophytes, non-dermatophyte molds, and bacteria.
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.
Of the remaining samples, 34% had bacterial species present.
Fungi only were present in less than 1% of samples.
Annette, et al. Fungal Diversity and Onychomycosis. J Am Podiatr Med Assoc 2019; 109(1): 57-63
What is onychomycosis?
Onychomycosis is a fungal infection of the nail. It is most commonly caused by a group of fungi called dermatophytes, the same fungi that cause athlete’s foot and is among the most common nail disorders in adults
When is onychomycosis treated?
Onychomycosis does not have to be treated in those patients considered just a cosmetic problem, but may prove bothersome because the infection will cause chronic discoloration and thickening of the nail. Patient concerns associated with onychomycoses include:
foot discomfort and pain
difficulty in wearing footwear and walking
cosmetic embarrassment
risk of infection spread to other family members
if disruption of integrity of the skin, provide an entry point for bacteria causing foot ulcers or cellulitis
The decision to treat an infection relies on the provider’s determination of severity of nail disease and what other chronic conditions exist where spread of the infection would be of concern for the patient’s health.
How is onychomycosis treated?
If your provider suspects you have an infection in a dystrophic nail, they will clip a portion of the nail and send to a lab to determine which organisms have infiltrated the nail to cause the infection. If an infection is present, it may be protected by biofilm making it more difficult to treat, especially with the nail make up of hard keratin and compact nature of the nail. Onychomycosis can be treated with antibiotics either orally or topically, with topical treatments preferred in patients:
greater than 65
immunocompromised
with chronic conditions like peripheral vascular disease, diabetes, liver or kidney disease
with drug interactions with other medications they are taking
How can the Duo-Step Nail Program help heal my nail infection?
Our program is designed to educate our patients and families on good nail hygiene. If an infection is identified, we partner with your provider to offer customized topical antibiotic prescriptions compounded in an ant-biofilm base to “clean up” the nail by removing the biofilm and treating the identified infection
Generally, a good nail hygiene program consists of:
nails well-trimmed and filed along their natural contour; do not cut into the corner of nails
diligently cleaning nail undersides frequently with soap and water
proper cleaning of grooming equipment (clippers and files) prior to use
sterilized equipment where nail tools are shared such as common in commercial nail salons
avoiding going barefoot in public places such as locker rooms and other athletic facilities
throwing away old or well-worn shoes as they may be contaminated with fungus or proactively disinfecting shoe insole to prevent fungal growth
wearing properly fitting shoes made of materials such as leather that allow the foot to “breathe”
wearing socks made to wick moisture from the skin
The Duo-Step Nail program offers a structured method to care for your infected nail by:
cleansing to breakdown debris and prep for treatment step
removing the biofilm protecting the bacteria
treating the underlying nail infection with Targeted Rx
As part of the Duo-Step Nail program, your prescription from the pharmacy will contain a topical compounded cleansing oil and a compounded antibiotic prescription customized to the bacterial or fungi present in your lab results, and contain the following instructions:
Cleansing Step:
Compound Cleansing Oil
PATIENT INSTRUCTIONS
Apply Ibuprofen 0.1% Compounded Cleansing Oil as first step of Duo-Step program prior to anti-infective Targeted Rx suspension therapy
Perform proper hand hygiene procedures as directed. Hands must be washed well before and after medication application.
Spray and massage cleansing formula to infected nail and nailbed using circular motions to break down debris and prep for treatment step. Rinse or wipe excess with damp cloth and gently pat dry.
Spray and massage cleansing formula to infected nail and nailbed using circular motions to break down debris and prep for treatment step. Rinse or wipe excess with damp cloth and gently pat dry.
Treatment Step:
Compounded Prescription Therapy Targeting the Nail Infection
PATIENT INSTRUCTIONS
After cleansing, apply the anti-infective compounded Targeted Rx suspension as second step of Duo-Step program to clear the nail infection.
After cleansing, apply prescription suspension topically to the infected toenail(s) and nailbed once daily or as directed by provider.
Store prescription at room temperature, away from direct heat and light.
Why Prescribe a Targeted Rx Compounded Anti-Biofilm + Anti-infective Topical Therapy Over Conventional Therapy?
| Duo-Step Nail Program | Comparison | Jublia® |
|---|---|---|
| No prior authorization required | PRIOR AUTHORIZATION | Prior Authorization required |
| Affordable compounded Targeted Rx combinations | AFFORDABILITY | Up to $650 if insurance does not cover |
| Biofilm disruption and penetration into nail bed | APPLICATION | Topical application to nail |
| Cleanse and apply suspension to infected nail(s) daily as directed for 12 weeks* | DURATION | Apply daily for up to one year |
| Mild site irritation reported* | SIDE EFFECTS** | Itching, burning, swelling, redness, ingrown toenails and pain at application site |
| Duo-Step Nail Program | Comparison | Itraconazole Oral | Terbinafine Oral |
|---|---|---|
| Biofilm disruption and penetration into nail bed | APPLICATION | Orally administered |
| Cleanse and apply suspension to infected nail(s) daily as directed for 12 weeks* | DURATION | Orally once daily for 12 weeks |
| Mild site irritation reported* | SIDE EFFECTS** | Both – Headache, rash, GI upset; Itraconazole – Hepatic toxicity; Terbinafine – Cholestatic hepatitis, blood dyscrasias, Stevens-Johnson syndrome |
| No known drug interations | INTERACTIONS** | Multiple drug interations |
*Source: pharmacy patient outcomes data |** Source: Jublia / Itraconazole / Terbinafine Package Insert
Frequently Asked Questions
Who are Customicro Clinical Services?
We are Clinician driven.
Customicro Clinical Services are supervised and administered by clinicians focused on antibiotic stewardship. We partner with pharmacies to dispense proprietary formulations and product options to manage the wound, sinus, and vaginal microenvironment including a 5R gut health program.
What does Customicro Clinical Services offer?
We service and administer solutions.
Our programs:
+ Offer personalized, patient-centered clinical formulations
+ Offer market leading specialized products
+ Offer a dedicated clinical pharmacist to support our partner providers
How do I partner with Customicro to offer their programs to my patients?
Please fill out our new accounts form and one of our team members will reach out to you as soon as possible. You can also contact us at directly at (480) - 490 - 8921.
Connect With Us
Customicro Clinical Services
10900 N Scottsdale Rd Ste 402, Scottsdale, AZ 85254
(480) - 490 - 8921
Our compounding pharmacy partner,
Customedico Pharmacy + Wellness
We are an independently owned compounding pharmacy dedicated to the provision of personalized medications to meet the unique needs of our patients. Please contact us with any questions or to participate in our programs.
10900 N. Scottsdale Rd #403, Scottsdale, AZ 85254
(480) - 946 - 9477
(480) - 946 - 1345
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