Tinea Pedis
Conditions
Brief summary
This is an open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The purpose of the current protocol is to establish the safety and tolerability of a single application of J. lividum to the feet of patients with proven T. pedis. In addition, the effect of J. lividum on the T. pedis will also be evaluated.
Detailed description
Open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The test product will be applied by study personnel at the investigational site. Each subject will have a single application of approximately 0.5 ml of the test article applied to each foot. Both affected and unaffected feet will be treated covering the web spaces, toes, toe nails as well as the plantar and lateral aspect of both feet. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits, if no significant tolerability or safety issues identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability of safety issues is identified the third cohort will be enrolled.
Interventions
DRUGJanthinobacterium lividum
Investigational Product
Sponsors
DermBiont, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single center open label dose escalating study design will be used in a population of patients with interdigital Tinea pedis. Each subject will have a single application of the test article applied to each foot. The three test articles will be a low dose, medium and a high dose of J. lividum. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits and if no significant tolerability of safety issues is identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability or safety issues are identified the third cohort will be enrolled. At all evaluations, signs and symptoms of application site reactions will be recorded at baseline, as well as days 2, 3, 7, 14, and 28.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to be included in the study: 1. Witnessed, signed informed consent approved by Institutional Review Board/Independent Ethics Committee. 2. A signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information. 3. Male Subjects of any race 18 years of age and older. 4. Subjects with a clinical diagnosis of interdigital T. pedis T. pedis interdigital defined as lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin). 5. Provisionally confirmed diagnosis at baseline by a positive potassium hydroxide (KOH) wet mount at the clinical site. 6. The sum of the clinical signs and symptoms scores of the target lesion is at least 4 using the Grading and signs and symptoms of T. pedis detailed in section 6.6.1, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling/fissures or pruritus/burning (on a scale of 0-3, where 2 indicates moderate severity). -
Exclusion criteria
Subjects with the following will be excluded from this study: 1. Any dermatological conditions that could interfere with clinical evaluations. 2. Any underlying disease(s) or some other dermatological condition that requires the use of interfering topical or systemic therapy. 3. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications applied to the foot: Topical astringents and abrasives (e.g. Burrow's solution) 1 week Topical antibiotics and antifungal on the infected area (e.g. Neomycin, Miconazole, Clotrimazole, Terbinafine) 2 weeks Anti-inflammatories, corticosteroids, topical immunomodulators (e.g. Pimecrolimus, Tacrolimus) 4 weeks 4. Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications: Corticosteroids (including intramuscular injections) (e.g. Triamcinolone acetonide) 4 weeks Antibiotics (e.g. Tetracycline, Cephalosporins, etc.) and/or Antifungal agents (e.g. Fluconazole, Itraconazole, Terbinafine, etc.) 4 weeks Systemic immunomodulators (e.g. Cyclophosphamide, Azathioprine, Biologicals-Monoclonal Antibodies. 4 weeks 5. Treatment of any type of cancer within the last 6 months. 6. History of any significant internal disease (which contraindicates use of live microbiome e.g. leukemia, liver failure, cardiovascular disease) 7. Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure. 8. AIDS or AIDS related complex by medical history. 9. Known or suspected immune suppressive medications or diseases. 10. Diabetes mellitus Type I or II by medical history. 11. Peripheral vascular disease based on medical history. 12. Any subject not able to meet the study attendance requirements. 13. Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation Cohort 1 | 28 days | Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe |
| Safety Evaluation Cohort 2 | 28 days | Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe |
| Safety Evaluation Cohort 3 | 28 days | Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe |
Countries
Dominican Republic
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Cohort 1 Dose 10\^6CFUs/ml of J. lividum
Janthinobacterium lividum: Investigational Product | 4 |
| Cohort 2 Cohort 2 Dose 10\^7CFUs/ml of J. lividum
Janthinobacterium lividum: Investigational Product | 4 |
| Cohort 3 Cohort 3 - Dose 10\^8CFUs/ml of J. Lividum
Janthinobacterium lividum: Investigational Product | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 13.74 | 46.8 years STANDARD_DEVIATION 3.3 | 35.8 years STANDARD_DEVIATION 15.95 | 42.5 years STANDARD_DEVIATION 12.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Safety Evaluation Cohort 1
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Time frame: 28 days
Population: By number of feet treated
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus 1 Hour Post application | 8 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus 1 Hour Post application | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus 1 Hour Post application | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pruritus Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Erythema Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Edema Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Scabbing Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 1 | Pain Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pain Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus 1 Hour Post application | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Pruritus Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Erythema 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Scabbing Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 1 | Edema 1 Hour Post | 0 Feet |
Primary
Safety Evaluation Cohort 2
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Time frame: 28 days
Population: By number of feet treated
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus 1 Hour Post application | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 3 | 8 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus 1 Hour Post application | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus 1 Hour Post application | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pruritus Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Erythema Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Edema Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Scabbing Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 2 | Pain Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Erythema Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus 1 Hour Post application | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pain Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Scabbing Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Edema Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 2 | Pruritus Baseline | 0 Feet |
Primary
Safety Evaluation Cohort 3
Tolerability will be evaluated through assessment of local signs and symptoms. For simplicity, as there were no local tolerability reactions, the cumulative tolerability, inclusive of Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging is represented in the table. Scoring for of each Pruritus, Erythema, Edema, Scabbing/crusting, and Burning/Stinging according to the scoring system below. Tolerability events were only considered adverse events if they were grade 3 or higher or required discontinuation of test article or use of conmeds. As no Tolerability events satisfied this criteria, there were no tolerability associated adverse events. 0 = none (complete absence) 1. = mild (slight) 2. = moderate (definitely present) 3. = Severe
Time frame: 28 days
Population: By number of feet treated
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus 1 Hour Post application | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Baseline | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 7 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 14 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 28 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 2 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 3 | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema 1 Hour Post | 8 Feet |
| 0=None Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 3 | 8 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus 1 Hour Post application | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 2 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 7 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 14 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Baseline | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 28 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 3 | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema 1 Hour Post | 0 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 2 | 00 Feet |
| 1=Mild Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus 1 Hour Post application | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pruritus Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Erythema Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Edema Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Scabbing Day 28 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Baseline | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain 1 Hour Post | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 2 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 3 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 7 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 14 | 0 Feet |
| 2=Moderate Count n=24 (Percentage) | Safety Evaluation Cohort 3 | Pain Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Erythema Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus 1 Hour Post application | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pain Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing 1 Hour Post | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing Day 2 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema Day 28 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing Day 3 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema Day 14 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Pruritus Baseline | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Scabbing Day 7 | 0 Feet |
| 3=Severe Count n=24 | Safety Evaluation Cohort 3 | Edema Day 3 | 0 Feet |