An interventional study of Ciclopirox Olamine Topical Suspension and Ciclopirox Topical Suspension 0.77%-Reference Product in Tinea Pedis, sponsored by Padagis LLC. Completed. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by Padagis LLC · Not applicable, Interventional, and Treatment
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.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 553 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Padagis LLC is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ciclopirox Olamine Topical Suspension
Drug: Ciclopirox Olamine Topical Suspension
Loprox® Topical Suspension 0.77%
Drug: Ciclopirox Topical Suspension 0.77%-Reference Product
placebo of test product
Drug: Ciclopirox Olamine Topical Suspension-Placebo
topical suspension
topical suspension
topical suspension
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
Proportion of Subjects With Mycological Cure
Potassium hydroxide \[KOH\] wet mount negative and fungal culture negative
Time frame: 6 weeks
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
| Milestone | Test Product | Reference Product | Vehicle Product |
|---|---|---|---|
| Started | 220 | 224 | 109 |
| Completed | 181 | 180 | 77 |
| Not completed | 39 | 44 | 32 |
| Withdrew: Lack of baseline fungus | 32 | 31 | 19 |
| Withdrew: Adverse event | 0 | 0 | 2 |
| Withdrew: Lack of efficacy | 1 | 1 | 3 |
| Withdrew: Protocol violation | 0 | 8 | 2 |
| Withdrew: Lost to follow-up | 3 | 3 | 4 |
| Withdrew: Withdrawal by subject | 3 | 1 | 2 |
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
| participants | Test Product | Reference Product | Vehicle Product |
|---|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | 93 | 88 | 7 |
Potassium hydroxide \[KOH\] wet mount negative and fungal culture negative
| participants | Test Product | Reference Product | Vehicle Product |
|---|---|---|---|
| Proportion of Subjects With Mycological Cure | 119 | 127 | 18 |
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
| participants | Test Product | Reference Product | Vehicle Product |
|---|---|---|---|
| Proportion of Subjects With Clinical Cure | 81 | 96 | 22 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | — | 0/220 (0%) | 0/220 (0%) |
| Reference Product | — | 2/224 (0.9%) | 0/224 (0%) |
| Vehicle Product | — | 4/109 (3.7%) | 0/109 (0%) |
| Event | Test Product | Reference Product | Vehicle Product |
|---|---|---|---|
| Chest painCardiac disorders | 0/220 | 0/224 | 1/109 |
| Subarachnoid hemorrhage; MCA aneurysm; PCOMNervous system disorders | 0/220 | 0/224 | 1/109 |
| Blood clots spleenGastrointestinal disorders | 0/220 | 0/224 | 1/109 |
| Seizures (transient ischaemic attack)Nervous system disorders | 0/220 | 0/224 | 1/109 |
| Perforated sigmoid colonGastrointestinal disorders | 0/220 | 1/224 | 0/109 |
| Right hip fractureMusculoskeletal and connective tissue disorders | 0/220 | 1/224 | 0/109 |
| Age, Categorical(Participants) | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| <=18 years | 10 | 13 | 4 | 27 |
| Between 18 and 65 years | 188 | 181 | 86 | 455 |
| >=65 years | 22 | 30 | 19 | 71 |
| Age, Continuous(years) | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| Mean | 43.5 ± 16.0 | 44.1 ± 16.5 | 47.7 ± 16.5 | 45.1 ± 16.3 |
| Sex: Female, Male(Participants) | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| Female | 65 | 68 | 33 | 166 |
| Male | 155 | 156 | 76 | 387 |
| Ethnicity (NIH/OMB)(Participants) | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| Hispanic or Latino | 55 | 60 | 26 | 141 |
| Not Hispanic or Latino | 165 | 164 | 83 | 412 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 1 | 3 |
| Asian | 2 | 5 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 37 | 26 | 21 | 84 |
| White | 178 | 192 | 82 | 452 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 | 4 |
| Region of Enrollment(participants) | Test Product | Reference Product | Vehicle Product | Total |
|---|---|---|---|---|
| United States | 220 | 224 | 109 | 553 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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