Trial Outcomes & Findings for Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis (NCT NCT00804193)
NCT ID: NCT00804193
Last Updated: 2021-10-27
Results Overview
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
553 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
Test Product
Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
|
Reference Product
Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
|
Vehicle Product
placebo of test product was applied treatment two times a day for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
220
|
224
|
109
|
|
Overall Study
COMPLETED
|
181
|
180
|
77
|
|
Overall Study
NOT COMPLETED
|
39
|
44
|
32
|
Reasons for withdrawal
| Measure |
Test Product
Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
|
Reference Product
Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
|
Vehicle Product
placebo of test product was applied treatment two times a day for 4 weeks
|
|---|---|---|---|
|
Overall Study
Lack of baseline fungus
|
32
|
31
|
19
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
3
|
|
Overall Study
Protocol Violation
|
0
|
8
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
2
|
Baseline Characteristics
Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis
Baseline characteristics by cohort
| Measure |
Test Product
n=220 Participants
Ciclopirox Olamine Topical Suspension
|
Reference Product
n=224 Participants
Loprox® Topical Suspension 0.77%
|
Vehicle Product
n=109 Participants
placebo of test product
|
Total
n=553 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
188 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
455 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 16.5 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 16.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
387 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
412 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
452 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
220 participants
n=5 Participants
|
224 participants
n=7 Participants
|
109 participants
n=5 Participants
|
553 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Per protocol population
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
Outcome measures
| Measure |
Test Product
n=149 Participants
Ciclopirox Olamine Topical Suspension
|
Reference Product
n=165 Participants
Loprox® Topical Suspension 0.77%
|
Vehicle Product
n=74 Participants
placebo of test product
|
|---|---|---|---|
|
Proportion of Subjects in Each Treatment Group With Therapeutic Success
|
93 participants
|
88 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 6 weeksPotassium hydroxide \[KOH\] wet mount negative and fungal culture negative
Outcome measures
| Measure |
Test Product
n=149 Participants
Ciclopirox Olamine Topical Suspension
|
Reference Product
n=165 Participants
Loprox® Topical Suspension 0.77%
|
Vehicle Product
n=74 Participants
placebo of test product
|
|---|---|---|---|
|
Proportion of Subjects With Mycological Cure
|
119 participants
|
127 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 6 weeksClinical 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
Outcome measures
| Measure |
Test Product
n=149 Participants
Ciclopirox Olamine Topical Suspension
|
Reference Product
n=165 Participants
Loprox® Topical Suspension 0.77%
|
Vehicle Product
n=74 Participants
placebo of test product
|
|---|---|---|---|
|
Proportion of Subjects With Clinical Cure
|
81 participants
|
96 participants
|
22 participants
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle Product
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product
n=220 participants at risk
Ciclopirox Olamine Topical Suspension
|
Reference Product
n=224 participants at risk
Loprox® Topical Suspension 0.77%
|
Vehicle Product
n=109 participants at risk
placebo of test product
|
|---|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/220
|
0.00%
0/224
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Perforated sigmoid colon
|
0.00%
0/220
|
0.45%
1/224 • Number of events 1
|
0.00%
0/109
|
|
Nervous system disorders
Subarachnoid hemorrhage; MCA aneurysm; PCOM
|
0.00%
0/220
|
0.00%
0/224
|
0.92%
1/109 • Number of events 1
|
|
Gastrointestinal disorders
Blood clots spleen
|
0.00%
0/220
|
0.00%
0/224
|
0.92%
1/109 • Number of events 1
|
|
Nervous system disorders
Seizures (transient ischaemic attack)
|
0.00%
0/220
|
0.00%
0/224
|
0.92%
1/109 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right hip fracture
|
0.00%
0/220
|
0.45%
1/224 • Number of events 1
|
0.00%
0/109
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER