Trial Outcomes & Findings for Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis (NCT NCT00802672)

NCT ID: NCT00802672

Last Updated: 2021-10-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 561 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2021-10-13

Participant Flow

Participant milestones

Measure	Test Product Ciclopirox cream	Reference Product Loprox Cream	Vehicle Product placebo
Overall Study STARTED	224	226	111
Overall Study COMPLETED	156	174	77
Overall Study NOT COMPLETED	68	52	34

Reasons for withdrawal

Measure	Test Product Ciclopirox cream	Reference Product Loprox Cream	Vehicle Product placebo
Overall Study Lack of fungal pathogen at baseline	56	43	25
Overall Study Adverse Event	1	1	1
Overall Study Protocol Violation	2	1	1
Overall Study Lost to Follow-up	5	5	3
Overall Study Withdrawal by Subject	1	1	2
Overall Study other	3	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Test Product n=224 Participants Ciclopirox cream	Reference Product n=226 Participants Loprox Cream	Vehicle Product n=111 Participants placebo	Total n=561 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	16 Participants n=7 Participants	6 Participants n=5 Participants	33 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	194 Participants n=5 Participants	189 Participants n=7 Participants	92 Participants n=5 Participants	475 Participants n=4 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	21 Participants n=7 Participants	13 Participants n=5 Participants	53 Participants n=4 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 15.6 • n=5 Participants	42.3 years STANDARD_DEVIATION 15.6 • n=7 Participants	43.1 years STANDARD_DEVIATION 15.1 • n=5 Participants	43.5 years STANDARD_DEVIATION 15.4 • n=4 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	63 Participants n=7 Participants	28 Participants n=5 Participants	144 Participants n=4 Participants
Sex: Female, Male Male	171 Participants n=5 Participants	163 Participants n=7 Participants	83 Participants n=5 Participants	417 Participants n=4 Participants
Region of Enrollment United States	224 participants n=5 Participants	226 participants n=7 Participants	111 participants n=5 Participants	561 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Per protocol population

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

Outcome measures

Measure	Test Product n=141 Participants Ciclopirox Olamine Cream, USP	Reference Product n=166 Participants Loprox® (ciclopirox) Cream 0.77%	Vehicle Product n=68 Participants Vehicle
Proportion of Subjects in Each Treatment Group With Therapeutic Success	70 participants	95 participants	3 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: per protocol population

Mycological Cure (KOH wet mount negative and fungal culture negative

Outcome measures

Measure	Test Product n=141 Participants Ciclopirox Olamine Cream, USP	Reference Product n=166 Participants Loprox® (ciclopirox) Cream 0.77%	Vehicle Product n=68 Participants Vehicle
Proportion of Subjects With Mycological Cure	107 participants	133 participants	9 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: per protocol population

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

Outcome measures

Measure	Test Product n=141 Participants Ciclopirox Olamine Cream, USP	Reference Product n=166 Participants Loprox® (ciclopirox) Cream 0.77%	Vehicle Product n=68 Participants Vehicle
Proportion of Subjects With Clinical Cure	82 participants	106 participants	9 participants

Adverse Events

Test Product

Serious events: 2 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: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Test Product n=224 participants at risk Ciclopirox Olamine Cream, USP	Reference Product n=226 participants at risk Loprox® (ciclopirox) Cream 0.77%	Vehicle Product n=111 participants at risk Vehicle
General disorders Pain secondary to head trauma	0.45% 1/224 • Number of events 1 • 6 weeks	0.00% 0/226 • 6 weeks	0.00% 0/111 • 6 weeks
Cardiac disorders Near syncope	0.00% 0/224 • 6 weeks	0.44% 1/226 • Number of events 1 • 6 weeks	0.00% 0/111 • 6 weeks
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/224 • 6 weeks	0.44% 1/226 • Number of events 1 • 6 weeks	0.00% 0/111 • 6 weeks
Cardiac disorders congestive heart failure	0.00% 0/224 • 6 weeks	0.00% 0/226 • 6 weeks	0.90% 1/111 • Number of events 1 • 6 weeks
Cardiac disorders Chest pain	0.45% 1/224 • Number of events 1 • 6 weeks	0.00% 0/226 • 6 weeks	0.90% 1/111 • Number of events 1 • 6 weeks

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Schwartz

Perrigo Company

Phone: 718-960-0119

Email: jonathan.schwartz@perrigo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER