Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00802672
• Collaborator: (none)
• Enrollment: 561
• Arms: 3
• Duration (Months): 5

Study Details

Study Description

Brief Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 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 Cream; Drug: Loprox Cream 0.77%; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 561 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 Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: May 1, 2004
• Actual Study Completion Date: May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Product Ciclopirox Olamine Cream 0.77%	Drug: Ciclopirox Olamine Cream; topical cream
Active Comparator: Reference Product Loprox Cream 0.77%	Drug: Loprox Cream 0.77%; topical cream; Other Names: Loprox Cream
Placebo Comparator: Vehicle Product placebo of test product	Drug: Placebo; topical cream

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects in Each Treatment Group With Therapeutic Success [6 weeks]

   Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success

Secondary Outcome Measures

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

   Mycological Cure (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 infecton 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: NCT00802672
• Other Study ID Numbers: CPL-302
• First Posted: Dec 5, 2008
• Last Update Posted: Oct 13, 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 cream	Loprox Cream	placebo
Period Title: Overall Study
STARTED	224	226	111
COMPLETED	156	174	77
NOT COMPLETED	68	52	34

Baseline Characteristics

Arm/Group Title	Test Product	Reference Product	Vehicle Product	Total
Arm/Group Description	Ciclopirox cream	Loprox Cream	placebo	Total of all reporting groups
Overall Participants	224	226	111	561
Age (Count of Participants)
<=18 years	11 4.9%	16 7.1%	6 5.4%	33 5.9%
Between 18 and 65 years	194 86.6%	189 83.6%	92 82.9%	475 84.7%
>=65 years	19 8.5%	21 9.3%	13 11.7%	53 9.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.2 (15.6)	42.3 (15.6)	43.1 (15.1)	43.5 (15.4)
Sex: Female, Male (Count of Participants)
Female	53 23.7%	63 27.9%	28 25.2%	144 25.7%
Male	171 76.3%	163 72.1%	83 74.8%	417 74.3%
Region of Enrollment (participants) [Number]
United States	224 100%	226 100%	111 100%	561 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects in Each Treatment Group With Therapeutic Success
Description	Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success
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 Cream, USP	Loprox® (ciclopirox) Cream 0.77%	Vehicle
Measure Participants	141	166	68
Number [participants]	70 31.3%	95 42%	3 2.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	For the primary efficacy analysis, a 90% confidence interval 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% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1
	Confidence Interval	(2-Sided) 90%; -17.61 to 2.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Proportion of Subjects With Mycological Cure
Description	Mycological Cure (KOH wet mount negative and fungal culture negative
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 Cream, USP	Loprox® (ciclopirox) Cream 0.77%	Vehicle
Measure Participants	141	166	68
Number [participants]	107 47.8%	133 58.8%	9 8.1%

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

per protocol population

Arm/Group Title	Test Product	Reference Product	Vehicle Product
Arm/Group Description	Ciclopirox Olamine Cream, USP	Loprox® (ciclopirox) Cream 0.77%	Vehicle
Measure Participants	141	166	68
Number [participants]	82 36.6%	106 46.9%	9 8.1%

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Test Product		Reference Product		Vehicle Product
Arm/Group Description	Ciclopirox Olamine Cream, USP		Loprox® (ciclopirox) Cream 0.77%		Vehicle
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	2/224 (0.9%)		2/226 (0.9%)		1/111 (0.9%)
Cardiac disorders
Near syncope	0/224 (0%)	0	1/226 (0.4%)	1	0/111 (0%)	0
congestive heart failure	0/224 (0%)	0	0/226 (0%)	0	1/111 (0.9%)	1
Chest pain	1/224 (0.4%)	1	0/226 (0%)	0	1/111 (0.9%)	1
General disorders
Pain secondary to head trauma	1/224 (0.4%)	1	0/226 (0%)	0	0/111 (0%)	0
Respiratory, thoracic and mediastinal disorders
pneumonia	0/224 (0%)	0	1/226 (0.4%)	1	0/111 (0%)	0
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	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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