Trial Outcomes & Findings for Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris (NCT NCT00750152)

Last Updated: 2013-04-22

Results Overview

Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

334 participants

Primary outcome timeframe

Week 4 post-baseline

Results posted on

2013-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	NAFT-500 Naftin 2% cream applied daily for 2 weeks	Placebo-2wks Placebo cream applied daily for 2 weeks
Overall Study STARTED	166	168
Overall Study COMPLETED	144	141
Overall Study NOT COMPLETED	22	27

Reasons for withdrawal

Reasons for withdrawal
Measure	NAFT-500 Naftin 2% cream applied daily for 2 weeks	Placebo-2wks Placebo cream applied daily for 2 weeks
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	8	13
Overall Study Withdrawal by Subject	3	3
Overall Study Physician Decision	1	1
Overall Study Non-compliance	0	1
Overall Study Termination by sponsor	1	0
Overall Study Other	7	8

Baseline Characteristics

Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAFT-500 n=166 Participants Naftin 2% cream applied daily for 2 weeks	Placebo-2wks n=168 Participants Placebo cream applied daily for 2 weeks	Total n=334 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	139 Participants n=5 Participants	149 Participants n=7 Participants	288 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Age Continuous	47.2 years STANDARD_DEVIATION 15.54 • n=5 Participants	46.2 years STANDARD_DEVIATION 14.53 • n=7 Participants	46.7 years STANDARD_DEVIATION 15.03 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants	138 Participants n=7 Participants	282 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants	113 participants n=7 Participants	225 participants n=5 Participants
Region of Enrollment Puerto Rico	54 participants n=5 Participants	55 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4 post-baseline

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

Outcome measures

Outcome measures
Measure	NAFT-500 n=75 Participants Naftin 2% cream applied daily for 2 weeks	Placebo-2wks n=71 Participants Placebo cream applied daily for 2 weeks
Percentage of Subjects	25.3 percentage of subjects with complete cur	2.8 percentage of subjects with complete cur

SECONDARY outcome

Timeframe: Week 4 (two weeks post-treatment)

Population: This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.

Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.

Outcome measures

Outcome measures
Measure	NAFT-500 n=75 Participants Naftin 2% cream applied daily for 2 weeks	Placebo-2wks n=71 Participants Placebo cream applied daily for 2 weeks
Mycological Cure and Treatment Effectiveness Mycological Cure (MC)	72.0 percentage of subjects	15.5 percentage of subjects
Mycological Cure and Treatment Effectiveness Treatment Effectiveness (TE)	60.0 percentage of subjects	9.9 percentage of subjects

Adverse Events

NAFT-500

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo-2wks

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NAFT-500 n=166 participants at risk Naftin 2% cream applied daily for 2 weeks	Placebo-2wks n=168 participants at risk Placebo cream applied daily for 2 weeks
Metabolism and nutrition disorders Dyslipidaemia	1.2% 2/166	1.2% 2/168
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/166	2.4% 4/168
Nervous system disorders Headache	1.2% 2/166	2.4% 4/168

Additional Information

Merz Pharmaceuticals, LLC

Phone: 800-334-0514

Results disclosure agreements

Principal investigator is a sponsor employee Institution and Principal Investigator agree not to individually publish the results of the Study. Institution and Principal Investigator may, however, upon written notice to Merz participate in a joint, multicenter publication of the Study results with other investigators and/or institutions, provided that the manuscript or abstract is first reviewed by Merz.
Publication restrictions are in place

Restriction type: OTHER