Laboratory Report 151128-150

Clinical Determination of the Antifungal Efficacy of One Test Product with Two Comparator Products Following the ASTM E2613 Standardized Test Method

SPONSOR
Human Health Foundation, LLC, 742 Goddard Avenue, Chesterfield, Missouri 63005

TESTING FACILITY
BioScience Laboratories, Inc., 1755 South 19th Avenue, Bozeman, Montana 59718

STUDY INITIATION DATE: Protocol 151128-150A: 12/08/15 • Protocol 151128-150B: 01/04/16
STUDY COMPLETION DATE: 04/11/16

The purpose of this study was to evaluate fungicidal activity of three test materials: one test product with two comparator products (Jublia® and Kerydin®), based upon the methodology described in ASTM E2613-14 Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults. The testing performed was used to evaluate the fungus-eliminating activity of the test materials on human skin contaminated with three fungal challenge strains, Aspergillus brasiliensis (ATCC #16404), Candida albicans (ATCC #10231), and Trichophyton rubrum (ATCC 28191).

A known volume of each challenge strain was placed on a site demarcated on each fingerpad and allowed to dry. On each subject, the thumb of each hand was used for the input control (recoverable population prior to drying). One of the two remaining digits on each hand, not including the ring or small finger, was assigned randomly to use for baseline control. The remaining fingerpad on each of the hands was exposed to the randomly assigned test material, for the specified contact time. Log10 CFU/mL and percent reduction in the titers of the challenge strains after treatment with the test materials was determined.

Efficacy Results

Test Product: Elastic Skin Liquid Bandage (Polyethylene Carbonate – Methylene Chloride); Lot Number B0802A produced mean reductions of Aspergillus brasiliensis (ATCC #16404) of 0.37 log10 on the fingerpads.

Comparator Product #1: Jublia® (10% Efinaconazole); Lot Number 000198A, 8084728, and 8084731 produced mean reductions of Aspergillus brasiliensis (ATCC #16404) of 0.19 log10 on the fingerpads.

Comparator Product #2: Kerydin® (5 % Tavaborole); Lot Number GFCM-1 and GFCN-1 produced mean reductions of Aspergillus brasiliensis (ATCC #16404) of 0.63 log10 on the fingerpads.

Test Product: Elastic Skin Liquid Bandage (Polyethylene Carbonate – Methylene Chloride); Lot Number B0802A produced mean reductions of Candida albicans (ATCC #10231) of 1.55 log10 on the fingerpads.

Comparator Product #1: Jublia® (10% Efinaconazole); Lot Number 000198A, 8084728, and 8084731 produced mean reductions of Candida albicans (ATCC #10231) of 1.39 log10 on the fingerpads.

Comparator Product #2: Kerydin® (5 % Tavaborole); Lot Number GFCM-1 and GFCN-1 produced mean reductions of Candida albicans (ATCC #10231) of 1.86 log10 on the fingerpads.

Test Product: Elastic Skin Liquid Bandage (Polyethylene Carbonate – Methylene Chloride); Lot Number B0802A produced mean reductions of Trichophyton rubrum (ATCC #28191) of 0.82 log10 on the fingerpads.

Comparator Product #1: Jublia® (10% Efinaconazole); Lot Number 000198A, 8084728, and 8084731 produced mean reductions of Trichophyton rubrum (ATCC #28191) of 1.27 log10 on the fingerpads.

Comparator Product #2: Kerydin® (5 % Tavaborole); Lot Number GFCM-1 and GFCN-1 produced mean reductions of Trichophyton rubrum (ATCC #28191) of 0.79 log10 on the fingerpads.

Conclusion

The fungicidal activity of the three products were not significantly different from each other over the three fungi, but the three fungi were significantly different from each other in their susceptibility to each individual test material. C. albicans was most effectively killed by all three materials, followed by T. rubrum and A. brasiliensis.

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