Trial Outcomes & Findings for Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis (NCT NCT00750139)
NCT ID: NCT00750139
Last Updated: 2013-04-26
Results Overview
The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6. The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6. Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.
COMPLETED
PHASE3
707 participants
Week 6
2013-04-26
Participant Flow
Participant milestones
| Measure |
NAFT-500
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-wks
Placebo applied daily for 2-weeks
|
Naftin 1%
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
Placebo cream applied daily for 4 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
234
|
118
|
236
|
119
|
|
Overall Study
COMPLETED
|
145
|
59
|
135
|
73
|
|
Overall Study
NOT COMPLETED
|
89
|
59
|
101
|
46
|
Reasons for withdrawal
| Measure |
NAFT-500
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-wks
Placebo applied daily for 2-weeks
|
Naftin 1%
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
Placebo cream applied daily for 4 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
17
|
12
|
15
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
6
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
1
|
3
|
|
Overall Study
Termination by sponsor
|
4
|
0
|
0
|
1
|
|
Overall Study
Non-specific
|
62
|
42
|
79
|
33
|
Baseline Characteristics
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
Baseline characteristics by cohort
| Measure |
NAFT-500
n=234 Participants
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-wks
n=118 Participants
Placebo applied daily for 2-weeks
|
Naftin 1%
n=236 Participants
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
n=119 Participants
Placebo cream applied daily for 4 weeks
|
Total
n=707 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
220 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
658 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age Continuous
|
42.7 years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 12.91 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 14.08 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 14.00 • n=4 Participants
|
41.7 years
STANDARD_DEVIATION 13.52 • n=21 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
205 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
502 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
234 participants
n=5 Participants
|
118 participants
n=7 Participants
|
236 participants
n=5 Participants
|
119 participants
n=4 Participants
|
707 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment.
The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6. The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6. Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.
Outcome measures
| Measure |
NAFT-500
n=147 Participants
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-weeks
n=70 Participants
Placebo Control cream applied daily for 2-weeks
|
Naftin 1%
n=143 Participants
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
n=65 Participants
Placebo control cream applied daily for 4 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects With Complete Cure at Week 6.
|
17.7 percentage of subjects with complete cur
|
7.1 percentage of subjects with complete cur
|
16.1 percentage of subjects with complete cur
|
3.1 percentage of subjects with complete cur
|
SECONDARY outcome
Timeframe: Week 6Population: This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment.
Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.
Outcome measures
| Measure |
NAFT-500
n=147 Participants
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-weeks
n=70 Participants
Placebo Control cream applied daily for 2-weeks
|
Naftin 1%
n=143 Participants
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
n=65 Participants
Placebo control cream applied daily for 4 weeks
|
|---|---|---|---|---|
|
Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6
Mycological Cure (MC)
|
67.3 percentage of Subjects
|
21.4 percentage of Subjects
|
71.3 percentage of Subjects
|
21.5 percentage of Subjects
|
|
Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6
Treatment Effectiveness (TE)
|
56.5 percentage of Subjects
|
20.0 percentage of Subjects
|
58.7 percentage of Subjects
|
13.8 percentage of Subjects
|
Adverse Events
NAFT-500
Placebo 2-wks
Naftin 1%
Placebo 4-wks
Serious adverse events
| Measure |
NAFT-500
n=234 participants at risk
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-wks
n=118 participants at risk
Placebo applied daily for 2-weeks
|
Naftin 1%
n=236 participants at risk
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
n=119 participants at risk
Placebo cream applied daily for 4 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/234
|
0.00%
0/118
|
0.42%
1/236
|
0.00%
0/119
|
Other adverse events
| Measure |
NAFT-500
n=234 participants at risk
Naftin 2% Cream applied daily for 2 weeks
|
Placebo 2-wks
n=118 participants at risk
Placebo applied daily for 2-weeks
|
Naftin 1%
n=236 participants at risk
Naftin 1% active comparator applied daily for 4 weeks
|
Placebo 4-wks
n=119 participants at risk
Placebo cream applied daily for 4 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.3%
10/234
|
3.4%
4/118
|
3.8%
9/236
|
2.5%
3/119
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
3/234
|
1.7%
2/118
|
2.1%
5/236
|
3.4%
4/119
|
|
General disorders
Application Site Irritation
|
1.7%
4/234
|
2.5%
3/118
|
1.7%
4/236
|
4.2%
5/119
|
|
General disorders
Application Site Pruritus
|
3.0%
7/234
|
3.4%
4/118
|
0.42%
1/236
|
2.5%
3/119
|
|
General disorders
Pain
|
1.7%
4/234
|
2.5%
3/118
|
1.7%
4/236
|
4.2%
5/119
|
|
General disorders
Application Site Dryness
|
1.7%
4/234
|
1.7%
2/118
|
0.42%
1/236
|
0.00%
0/119
|
|
Investigations
Blood Creatinine Increased
|
0.43%
1/234
|
1.7%
2/118
|
0.85%
2/236
|
0.84%
1/119
|
|
Investigations
Alanine Aminotransferase Increased
|
0.43%
1/234
|
0.00%
0/118
|
0.85%
2/236
|
1.7%
2/119
|
|
Investigations
Blood Glucose Increased
|
0.43%
1/234
|
1.7%
2/118
|
0.00%
0/236
|
0.84%
1/119
|
|
Investigations
Protein Urine Present
|
0.43%
1/234
|
1.7%
2/118
|
0.00%
0/236
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
2/234
|
1.7%
2/118
|
1.3%
3/236
|
1.7%
2/119
|
Additional Information
Associate Medical Director- Dermatology
Merz Pharmaceuticals, LLC
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