Trial Outcomes & Findings for Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis (NCT NCT01289015)

NCT ID: NCT01289015

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: 855 participants
• Primary outcome timeframe: Visit 4/ Week 6
• Results posted on: 2013-09-26

Participant Flow

Participant milestones

Measure	NAFT-600 NAFT-600 : Topical; applied once daily for two weeks	Placebo Placebo : Topical; applied once daily for two weeks
Overall Study STARTED	571	284
Overall Study COMPLETED	472	230
Overall Study NOT COMPLETED	99	54

Reasons for withdrawal

Measure	NAFT-600 NAFT-600 : Topical; applied once daily for two weeks	Placebo Placebo : Topical; applied once daily for two weeks
Overall Study Protocol Violation	12	9
Overall Study Adverse Event	3	0
Overall Study Lost to Follow-up	33	17
Overall Study Withdrawal by Subject	17	8
Overall Study Disease progression	1	0
Overall Study Negative baseline culture and others	33	20

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NAFT-600 n=571 Participants NAFT-600 : Topical; applied once daily for two weeks	Placebo n=284 Participants Placebo : Topical; applied once daily for two weeks	Total n=855 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	524 Participants n=93 Participants	255 Participants n=4 Participants	779 Participants n=27 Participants
Age, Categorical >=65 years	42 Participants n=93 Participants	27 Participants n=4 Participants	69 Participants n=27 Participants
Age Continuous	45.3 years STANDARD_DEVIATION 13.3 • n=93 Participants	46.4 years STANDARD_DEVIATION 14.3 • n=4 Participants	45.7 years STANDARD_DEVIATION 13.6 • n=27 Participants
Sex: Female, Male Female	416 Participants n=93 Participants	221 Participants n=4 Participants	637 Participants n=27 Participants
Sex: Female, Male Male	155 Participants n=93 Participants	63 Participants n=4 Participants	218 Participants n=27 Participants
Region of Enrollment United States	545 participants n=93 Participants	271 participants n=4 Participants	816 participants n=27 Participants
Region of Enrollment Puerto Rico	26 participants n=93 Participants	13 participants n=4 Participants	39 participants n=27 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 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=382 Participants NAFT-600 : Topical; applied once daily for two weeks	Placebo n=179 Participants Placebo : Topical; applied once daily for two weeks
Complete Cure of Interdigital Tinea Pedis	16.8 percentage of subjects	1.7 percentage of subjects

SECONDARY outcome

Timeframe: Visit 4/ Week 6.

Population: Full Analysis Set (FAS) using a Modified Intent to Treat 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=382 Participants NAFT-600 : Topical; applied once daily for two weeks	Placebo n=179 Participants Placebo : Topical; applied once daily for two weeks
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 Mycological Cure	65.4 percentage of subjects	14.0 percentage of subjects
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 Effective Treatment	54.2 percentage of subjects	6.1 percentage of subjects

Adverse Events

NAFT-600

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	NAFT-600 n=571 participants at risk NAFT-600 : Topical; applied once daily for two weeks	Placebo n=284 participants at risk Placebo : Topical; applied once daily for two weeks
Injury, poisoning and procedural complications Skull Fractured Base	0.18% 1/571 • Adverse events were collected up to Week 6.	0.00% 0/284 • Adverse events were collected up to Week 6.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.18% 1/571 • Adverse events were collected up to Week 6.	0.00% 0/284 • Adverse events were collected up to Week 6.
Infections and infestations Abscess	0.00% 0/571 • Adverse events were collected up to Week 6.	0.35% 1/284 • Adverse events were collected up to Week 6.
Infections and infestations Respiratory Tract Infection	0.00% 0/571 • Adverse events were collected up to Week 6.	0.35% 1/284 • Adverse events were collected up to Week 6.

Other adverse events

Measure	NAFT-600 n=571 participants at risk NAFT-600 : Topical; applied once daily for two weeks	Placebo n=284 participants at risk Placebo : Topical; applied once daily for two weeks
Nervous system disorders Headache	2.3% 13/571 • Adverse events were collected up to Week 6.	0.70% 2/284 • 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