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NAILSTAT FORMULA CLINICAL STUDY

RESEARCH OBJECTIVE

It is important for Tripod Labs, Inc. to measure the effectiveness of its two-step Nailstat™ Formula for the treatment of onychomycosis. In addition, we are interested in the following:

  • Success of the Nailstat™ Formula as compared to other topical treatments.
  • Effectiveness of the Nailstat™ Formula of just using " step 2 " alone.

METHODOLOGY

A total of 165 patients were selected, treated and monitored over the course of a one year period. Observations were made at the following intervals: 1 month, 3 months, 6 months, and 1 year.

All patients had to meet these criteria:
  • All must have had more than one nail involved, and must have had at least 1/2 the nail infected.
  • The nails must had to have been infected for at least 1 year.
Of these patients:
  • 85% had tried using at least one other topical treatment.
  • 35% had considered oral antifungals.
  • 15% already had taken an oral antifungal and experienced a recurrence.
  • 90% were mostly concerned with the cosmetic appearance of their nails.
KEY FINDINGS
After 1 month of treatment:
  • 80% noticed a palpable softening of the nail plate.
  • 50% saw signs of visible improvement of their condition.
  • 90% of patients who tried other topicals felt they were seeing greater progress with Nailstat™ Formula.
After 3 months:
  • 70% saw improvement of their condition.
  • 75% felt they could trim nails more easily.
  • 90% of patients using just step 2 on one foot and both steps on the other foot saw a dramatic difference in permeability of the nail plate, as well as a marked improvement of the nails treated with both steps, as compared to those just treated with step 2.
After 6 months:
  • 75% saw marked improvement of their condition.
  • 75% felt they could trim nails more easily.
  • 90% of patients were happy with the progress with Nailstat™ Formula to this point.
  • 35% had complete resolution of the fungal nails.
After 1 year:
  • 80% stated there was at least a 50% improvement in their condition.
  • 90% of patients having used other topicals stated that Nailstat™ Formula yielded the greatest result.
  • 43% saw complete resolution in at least 1 nail.
CONCLUSIONS

Nearly all patients treated noticed at least some positive change in their condition after just 3 months of treatment, and many had a complete resolution of the involved nails after 6 months. In addition, the vast majority (90%) preferred Nailstat Formula to other topical antifungal products.

Note: Results of actual clinical trial are pending publication.

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