NAILSTAT™ FORMULA CLINICAL STUDY by Tripod Labs, Inc.™
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.
