Tinea Pedis
Conditions
Keywords
Tinea Pedis, Ciclopirox Olamine
Brief summary
The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.
Interventions
DRUGCiclopirox Olamine Topical Suspension
topical suspension
DRUGCiclopirox Topical Suspension 0.77%-Reference Product
topical suspension
DRUGCiclopirox Olamine Topical Suspension-Placebo
topical suspension
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female at least 10 years of age, and otherwise healthy * Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis * In good health with no clinically significant disease that might have interfered with study evaluations * Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.
Exclusion criteria
* History of hypersensitivity or allergy to ciclopirox * Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis * Had a history of dermatophyte infection unresponsive to antifungal treatment * Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study * Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk * Was unwilling to sign the informed consent * Female who was pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | 6 weeks | Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Mycological Cure | 6 weeks | Potassium hydroxide \[KOH\] wet mount negative and fungal culture negative |
| Proportion of Subjects With Clinical Cure | 6 weeks | Clinical Cure was defined as a signs and symptoms score of \<1 for erythema; \<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Product Ciclopirox Olamine Topical Suspension | 220 |
| Reference Product Loprox® Topical Suspension 0.77% | 224 |
| Vehicle Product placebo of test product | 109 |
| Total | 553 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 |
| Overall Study | Lack of baseline fungus | 32 | 31 | 19 |
| Overall Study | Lack of Efficacy | 1 | 1 | 3 |
| Overall Study | Lost to Follow-up | 3 | 3 | 4 |
| Overall Study | Protocol Violation | 0 | 8 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 13 Participants | 4 Participants | 27 Participants |
| Age, Categorical >=65 years | 22 Participants | 30 Participants | 19 Participants | 71 Participants |
| Age, Categorical Between 18 and 65 years | 188 Participants | 181 Participants | 86 Participants | 455 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 16 | 44.1 years STANDARD_DEVIATION 16.5 | 47.7 years STANDARD_DEVIATION 16.5 | 45.1 years STANDARD_DEVIATION 16.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 60 Participants | 26 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants | 164 Participants | 83 Participants | 412 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 26 Participants | 21 Participants | 84 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 178 Participants | 192 Participants | 82 Participants | 452 Participants |
| Region of Enrollment United States | 220 participants | 224 participants | 109 participants | 553 participants |
| Sex: Female, Male Female | 65 Participants | 68 Participants | 33 Participants | 166 Participants |
| Sex: Female, Male Male | 155 Participants | 156 Participants | 76 Participants | 387 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 220 | 0 / 224 | 0 / 109 |
| serious Total, serious adverse events | 0 / 220 | 2 / 224 | 4 / 109 |
Outcome results
Primary
Proportion of Subjects in Each Treatment Group With Therapeutic Success
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
Time frame: 6 weeks
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Proportion of Subjects in Each Treatment Group With Therapeutic Success | 93 participants |
| Reference Product | Proportion of Subjects in Each Treatment Group With Therapeutic Success | 88 participants |
| Vehicle Product | Proportion of Subjects in Each Treatment Group With Therapeutic Success | 7 participants |
90% CI: [-0.69, 18.85]Wald's method, Yates
Secondary
Proportion of Subjects With Clinical Cure
Clinical Cure was defined as a signs and symptoms score of \<1 for erythema; \<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Proportion of Subjects With Clinical Cure | 81 participants |
| Reference Product | Proportion of Subjects With Clinical Cure | 96 participants |
| Vehicle Product | Proportion of Subjects With Clinical Cure | 22 participants |
p-value: 0.00190% CI: [-4.6, 14.24]Wald's method Yates' continuity cor
Secondary
Proportion of Subjects With Mycological Cure
Potassium hydroxide \[KOH\] wet mount negative and fungal culture negative
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Proportion of Subjects With Mycological Cure | 119 participants |
| Reference Product | Proportion of Subjects With Mycological Cure | 127 participants |
| Vehicle Product | Proportion of Subjects With Mycological Cure | 18 participants |
p-value: 0.00190% CI: [-7.08, 9.24]Wald's method with Yates' continuity cor