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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00804193
• Collaborator: (none)
• Enrollment: 553
• Arms: 3
• Duration (Months): 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: Ciclopirox Olamine Topical Suspension; Drug: Ciclopirox Topical Suspension 0.77%-Reference Product; Drug: Ciclopirox Olamine Topical Suspension-Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 553 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Dec 1, 2004
• Actual Study Completion Date: Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Product Ciclopirox Olamine Topical Suspension	Drug: Ciclopirox Olamine Topical Suspension; topical suspension
Active Comparator: Reference Product Loprox® Topical Suspension 0.77%	Drug: Ciclopirox Topical Suspension 0.77%-Reference Product; topical suspension
Placebo Comparator: Vehicle Product placebo of test product	Drug: Ciclopirox Olamine Topical Suspension-Placebo; topical suspension

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Proportion of Subjects With Mycological Cure [6 weeks]

   Potassium hydroxide [KOH] wet mount negative and fungal culture negative

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT00804193
• Other Study ID Numbers: CPL-402
• First Posted: Dec 8, 2008
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Padagis LLC: Tinea Pedis; Ciclopirox Olamine
• Additional relevant MeSH terms: Tinea; Tinea Pedis; Ciclopirox

Study Results

Participant Flow

Arm/Group Title	Test Product	Reference Product	Vehicle Product
Arm/Group Description	Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks	Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks	placebo of test product was applied treatment two times a day for 4 weeks
Period Title: Overall Study
STARTED	220	224	109
COMPLETED	181	180	77
NOT COMPLETED	39	44	32

Baseline Characteristics

Arm/Group Title	Test Product	Reference Product	Vehicle Product	Total
Arm/Group Description	Ciclopirox Olamine Topical Suspension	Loprox® Topical Suspension 0.77%	placebo of test product	Total of all reporting groups
Overall Participants	220	224	109	553
Age (Count of Participants)
<=18 years	10 4.5%	13 5.8%	4 3.7%	27 4.9%
Between 18 and 65 years	188 85.5%	181 80.8%	86 78.9%	455 82.3%
>=65 years	22 10%	30 13.4%	19 17.4%	71 12.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.5 (16.0)	44.1 (16.5)	47.7 (16.5)	45.1 (16.3)
Sex: Female, Male (Count of Participants)
Female	65 29.5%	68 30.4%	33 30.3%	166 30%
Male	155 70.5%	156 69.6%	76 69.7%	387 70%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	55 25%	60 26.8%	26 23.9%	141 25.5%
Not Hispanic or Latino	165 75%	164 73.2%	83 76.1%	412 74.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.9%	0 0%	1 0.9%	3 0.5%
Asian	2 0.9%	5 2.2%	2 1.8%	9 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 0.9%	1 0.2%
Black or African American	37 16.8%	26 11.6%	21 19.3%	84 15.2%
White	178 80.9%	192 85.7%	82 75.2%	452 81.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.5%	1 0.4%	2 1.8%	4 0.7%
Region of Enrollment (participants) [Number]
United States	220 100%	224 100%	109 100%	553 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects in Each Treatment Group With Therapeutic Success
Description	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

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	Test Product	Reference Product	Vehicle Product
Arm/Group Description	Ciclopirox Olamine Topical Suspension	Loprox® Topical Suspension 0.77%	placebo of test product
Measure Participants	149	165	74
Number [participants]	93 42.3%	88 39.3%	7 6.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage of Participants
	Estimated Value	9
	Confidence Interval	(2-Sided) 90%; -0.69 to 18.85
	Parameter Dispersion	Type: Value:
	Estimation Comments	The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.

2. Secondary Outcome

Title	Proportion of Subjects With Mycological Cure
Description	Potassium hydroxide [KOH] wet mount negative and fungal culture negative
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Product	Reference Product	Vehicle Product
Arm/Group Description	Ciclopirox Olamine Topical Suspension	Loprox® Topical Suspension 0.77%	placebo of test product
Measure Participants	149	165	74
Number [participants]	119 54.1%	127 56.7%	18 16.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wald's method with Yates' continuity cor
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage of Participants
	Estimated Value	1
	Confidence Interval	(2-Sided) 90%; -7.08 to 9.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.

3. Secondary Outcome

Title	Proportion of Subjects With Clinical Cure
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Product	Reference Product	Vehicle Product
Arm/Group Description	Ciclopirox Olamine Topical Suspension	Loprox® Topical Suspension 0.77%	placebo of test product
Measure Participants	149	165	74
Number [participants]	81 36.8%	96 42.9%	22 20.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wald's method Yates' continuity cor
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage of Participants
	Estimated Value	4
	Confidence Interval	(2-Sided) 90%; -4.60 to 14.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.

Adverse Events

Arm/Group Title	Test Product		Reference Product		Vehicle Product
Arm/Group Description	Ciclopirox Olamine Topical Suspension		Loprox® Topical Suspension 0.77%		placebo of test product
All Cause Mortality
	Test Product		Reference Product		Vehicle Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test Product		Reference Product		Vehicle Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		2/224 (0.9%)		4/109 (3.7%)
Cardiac disorders
Chest pain	0/220 (0%)	0	0/224 (0%)	0	1/109 (0.9%)	1
Gastrointestinal disorders
Perforated sigmoid colon	0/220 (0%)	0	1/224 (0.4%)	1	0/109 (0%)	0
Blood clots spleen	0/220 (0%)	0	0/224 (0%)	0	1/109 (0.9%)	1
Musculoskeletal and connective tissue disorders
Right hip fracture	0/220 (0%)	0	1/224 (0.4%)	1	0/109 (0%)	0
Nervous system disorders
Subarachnoid hemorrhage; MCA aneurysm; PCOM	0/220 (0%)	0	0/224 (0%)	0	1/109 (0.9%)	1
Seizures (transient ischaemic attack)	0/220 (0%)	0	0/224 (0%)	0	1/109 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Test Product		Reference Product		Vehicle Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/220 (0%)		0/224 (0%)		0/109 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.