Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis (NCT NCT01290341)

NCT ID: NCT01290341

Last Updated: 2013-09-26

Results Overview

The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 860 participants
• Primary outcome timeframe: Visit 4/ Week 6
• Results posted on: 2013-09-26

Participant Flow

Participant milestones

Measure	NAFT-600 Topical; applied once daily for two weeks	Placebo Topical; applied once daily for two weeks.
Overall Study STARTED	573	287
Overall Study COMPLETED	481	258
Overall Study NOT COMPLETED	92	29

Reasons for withdrawal

Measure	NAFT-600 Topical; applied once daily for two weeks	Placebo Topical; applied once daily for two weeks.
Overall Study Protocol Violation	7	3
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	21	10
Overall Study Withdrawal by Subject	19	5
Overall Study Negative baseline culture and others	44	11

Baseline Characteristics

Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

Baseline characteristics by cohort

Measure	NAFT-600 n=572 Participants Topical; applied once daily for two weeks	Placebo n=287 Participants Topical; applied once daily for two weeks.	Total n=859 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	500 Participants n=5 Participants	252 Participants n=7 Participants	752 Participants n=5 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants	31 Participants n=7 Participants	88 Participants n=5 Participants
Age Continuous	45.2 years STANDARD_DEVIATION 14.9 • n=5 Participants	45.2 years STANDARD_DEVIATION 14.7 • n=7 Participants	45.2 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants	73 Participants n=7 Participants	191 Participants n=5 Participants
Sex: Female, Male Male	454 Participants n=5 Participants	214 Participants n=7 Participants	668 Participants n=5 Participants
Region of Enrollment United States	572 participants n=5 Participants	287 participants n=7 Participants	859 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 4/ Week 6

Population: Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.

The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.

Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.

Outcome measures

Measure	NAFT-600 n=400 Participants Topical; applied once daily for two weeks	Placebo n=213 Participants Topical; applied once daily for two weeks.
Complete Cure of Interdigital Tinea Pedis	26.0 percentage of subjects	3.3 percentage of subjects

SECONDARY outcome

Timeframe: Visit 4/ Week 6

Population: Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population.

Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).

Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.

Outcome measures

Measure	NAFT-600 n=400 Participants Topical; applied once daily for two weeks	Placebo n=213 Participants Topical; applied once daily for two weeks.
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 Mycological Cure	58.8 percentage of subjects	10.3 percentage of subjects
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 Effective Treatment	50.8 percentage of subjects	7.0 percentage of subjects

Adverse Events

NAFT-600

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	NAFT-600 n=572 participants at risk Topical; applied once daily for two weeks	Placebo n=287 participants at risk Topical; applied once daily for two weeks.
Renal and urinary disorders Urethral Stenosis	0.17% 1/572 • Adverse Events were collected up to Week 6.	0.00% 0/287 • Adverse Events were collected up to Week 6.
Infections and infestations Appendicitis	0.00% 0/572 • Adverse Events were collected up to Week 6.	0.35% 1/287 • Adverse Events were collected up to Week 6.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/572 • Adverse Events were collected up to Week 6.	0.35% 1/287 • Adverse Events were collected up to Week 6.

Other adverse events

Measure	NAFT-600 n=572 participants at risk Topical; applied once daily for two weeks	Placebo n=287 participants at risk Topical; applied once daily for two weeks.
Nervous system disorders Headache	2.8% 16/572 • Adverse Events were collected up to Week 6.	1.7% 5/287 • Adverse Events were collected up to Week 6.

Additional Information

Stefan Plaum, MD Associate Medical Director

Merz Pharmaceuticals, LLC

Phone: 800-334-0514

Email: clinicaltrials@merzusa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution and Principal Investigator agreed not to individually publish or assist other person or entity with any articles, papers, and/or make presentations, speeches referring to the protocol, clinical trial data, the study, or the study drug or any data, results, materials, or information generated or obtained by the Institution or the Principal Investigator without the prior written consent of Merz, which consent may be withheld in the sole discretion of Merz.
• Publication restrictions are in place

Restriction type: OTHER