ABSTRACT
Background: Tinea pedis is the most common dermatophyte infection. Treatment is critical in order 
to alleviate pruritic symptoms, to reduce the risk for secondary bacterial infection, and to limit the 
spread of infection to other body sites or other individuals. Topical antifungal foams are effective 
in treating interdigital tinea pedis, but little is known about how clinical efficacy of antifungal foams 
impact quality of life as compared to traditional antifungal creams.
Study Design: A single-center, investigator blinded, observational split body, pilot study was 
conducted to compare econazole nitrate topical foam, 1% to ketoconazole cream 2%. All 20 
subjects received econazole nitrate topical foam, 1% and ketoconazole cream 2% to either right or 
left foot for 14 days. Improvements in patient quality of life and patient preference were measured 
using the pruritus visual analog scale 0/AS), Skindex-16, and patient preference questionnaires.
Results: Nineteen subjects completed the study and one subject was lost to follow-up. Both 
econazole nitrate topical foam, 1% and ketoconazole cream 2% were effective in reducing pruritic 
symptoms as measured by the pruritus VAS. The reductions in VAS exhibited by econazole nitrate 
topical foam, 1% were significantly greater than those exhibited by ketoconazole cream 2%. Patient 
symptom, emotional, functional and total scores from the Skindex-16 were significantly reduced by 
the final visit. Patients did not exhibit a significant preference for either econazole nitrate topical 
foam, 1% or ketoconazole cream 2% on patient preference questionnaires. One adverse event was 
reported with no further details provided.
Conclusion: While patient preference was equal for the two study medications, econazole nitrate 
topical foam, 1% had increased reductions in pruritus VAS scores compared to ketoconazole 
cream 2%. This suggests that econazole nitrate topical foam, 1% is both clinically effective and has 
meaningful improvements in patient quality of life.

INTRODUCTION
• Tinea pedis is the most common dermatophyte infection. Results from the National Ambulatory 

Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey 
(NHAMCS) (1995-2004) indicated an average of 4,124,038 annual visits for dermatophytoses 
during the study period with tinea pedis accounting for 18.8% (1).

• Treatment is critical in order to alleviate pruritic symptoms, to reduce the risk for secondary 
bacterial infection, and to limit the spread of infection to other body sites or other individuals 
(2, 3).

• Topical antifungal foams are effective in treating interdigital tinea pedis, but little is known 
about how clinical efficacy of antifungal foams impact quality of life as compared to traditional 
antifungal creams.

OBJECTIVE
• To compare the efficacy of and patient preference for econazole nitrate topical foam, 1% versus 

those of ketoconazole cream 2% on the signs and symptoms of interdigital tinea pedis.

SUBJECTS AND METHODS
Study Design

• Single-center, investigator blinded, observational, split body, pilot study 
• All subjects applied econazole nitrate topical foam, 1% (Ecoza foam) and ketoconazole cream 

2% (Nizoral Cream) to either the right or left foot. Study medication was applied twice daily; 
once in the morning, and once in the evening.

• The duration of the study was 14 days and consisted of a baseline visit and a final visit at the 
end of 14 days of treatment.

Subjects
• Male and female outpatients ≥18 years of age or older
• Pruritus visual analog scale (VAS) score >5
• Positive KOH preparation at baseline
• Able to understand study requirements and sign Informed Consent/HIPAA Authorization forms
• Female patients of child-bearing potential were required to have a negative urine pregnancy 

test and to practice a reliable method of contraception throughout the study.

ASSESSMENTS
Efficacy

• Pruritus VAS: at each study visit, subjects assessed the severity of pruritus using a 10-cm VAS 
with the left side of the scale anchored with “No Itch” and the right side of the scale anchored 
with “Worst imaginable itch”.

• Skindex-16: subjects completed the Skindex-16 at baseline and the final study visit. The 
Skindex-16 is a short 16-item patient-completed assessment using numerical analogue scales 
(0 = never bothered to 6 = always bothered). Responses to the Skindex-16 are categorized into 
three subscales: symptom, emotional, and functional (4).

Treatment Preference
• Subjects also completed a treatment preference questionnaire at the end of the study.

Safety
• Subjects were monitored for signs and symptoms of adverse events (AEs) throughout the study.

DATA ANALYSIS
• All analyses were conducted on an intent-to-treat population that included all subjects who 

were enrolled and received study medication. 

• Descriptive statistics (mean, standard deviation, etc.) were provided for all continuous variables 
and frequencies for all categorical variables.

• Differences between study treatments were evaluated using analyses of covariance (ANCOVA) 
with baseline values for variables measured as covariates.

• All statistical tests were two-sided and interpreted at a 5% significance level.

RESULTS
SUBJECTS

• Twenty subjects (11 males, 9 females; 16 white, 4 black; age 46 ± 16 years [range = 18-68 
years]) were enrolled. 

• Ten subjects were randomly assigned to econazole nitrate topical foam, 1% on the left foot and 
ketoconazole cream 2% on the right foot; and 10 were randomized to receive econazole nitrate 
topical foam, 1% on the right foot and ketoconazole cream 2% on the left foot. 

• One subject was lost to follow-up and all efficacy analyses were based on results for 19 
subjects. 

EFFICACY
Pruritus VAS

• There were substantial reductions from baseline in pruritus VAS scores for both econazole 
nitrate topical foam, 1% (P=0.0001) and ketoconazole cream 2% (P=0.001) (Figure 1). 

• The mean reduction observed for the feet treated with econazole nitrate topical foam, 1% 
was significantly greater than mean reduction observed for the feet treated with ketoconazole 
cream 2% (P=0.006) (Figure 1).

Skindex-16
• There were significant decreases in the Skindex-16 domain scores from baseline to the final visit 

(all P<0.01) (Figure 2). 
• It should be noted that no econazole nitrate topical foam, 1% vs ketoconazole cream 

2% comparisons were possible for the Skindex-16 data, since all patients received both 
medications and the questions of the Skindex-16 were not medication-specific.

Figure 1. Results for Pruritus VAS

8.3 8.3

4.3

1.5

Econazole Nitrate Topical Foam, 1%
Ketoconazole Cream, 2%

Baseline Day 14

‡

* P=0.0001 vs baseline; ‡ P=0.001 vs baseline,

* †

† P=0.006 vs Ketoconazole Cream, 2%

Error bars are standard deviations

10

9

M
ea

n 
P

ru
ri

tu
s 

VA
S 8

7

6

5

4

3

2

1

0

Figure 2. Results for Skindex-16

TotalFunctionalEmotionalSymptom

Error bars are standard deviations

P=0.0002

M
ea

n 
S

ki
nd

ex
-1

6 
S

co
re

s P=0.001 P=0.007 P=0.003

Baseline Day 146

5

4

3

2

1

0

3.4
3.0

3.0
3.8

1.5 1.7

0.9

1.6

Subject Ratings
• There were no significant differences in patient preference on any item of the questionnaire 

between econazole nitrate topical foam, 1% and ketoconazole cream 2% (all P>0.05).

• Econazole nitrate topical foam, 1% had median ratings of good or excellent on all measures 
assessed (Figure 3).

Figure 3. Subject ratings of econazole nitrate topical foam, 1%

Easy to apply

Fragrance free

Spreadability

Lack of stickiness

Moisturizing

Lack of residue

Not greasy

Permitted continuation of activites

Easy to use

Median Rating

Skin felt soft

Disappears quickly

Absorbs quickly

543210

5 = Excellent
4 = Good
3 = Fair
2 = Poor
1 = Very Poor

SAFETY
• One AE was noted, but no further details were provided.

CONCLUSIONS
• Econazole nitrate topical foam, 1% was significantly superior to ketoconazole cream 2% 

for decreasing pruritus VAS scores over 2 weeks of treatment in patients with tinea pedis.
• Treatment also significantly decreased Skindex-16 total scores and scores for all domains 

comprising this measure.
• Subject rated econazole nitrate topical foam, 1% as good or excellent for all properties 

evaluated.
• All of these results support the conclusion that econazole nitrate topical foam, 1% is 

clinically effective, easy to use, and provides meaningful improvements in patient quality 
of life.

REFERENCES
1. Panackal AA, Halpern EF, Watson AJ. Int J Dermatol. 2009;48(7):704-12.
2. Sahoo AK, Mahajan R. Indian Dermatol Online J. 2016;7(2):77-86.
3.  Moriarty B, Hay R, Morris-Jones R. The diagnosis and management of tinea. BMJ. 

2012;345:e4380. 
4. Chren MM, Lasek RJ, Sahay AP, et al. J Cuttan Med Surg. 2001;5(2):105-10.

The Effect of Econazole Nitrate Topical Foam, 1% on Signs and Symptoms 
(Pruritus) of lnterdigital Tinea Pedis 

Lauren K. Hoffman1, Isabelle Raymond, PhD2, Leon Kircik, MD3,, 1 Albert Einstein College of Medicine, Bronx NY, 2 Exeltis USA, Florham Park, NJ, 3 Mount Sinai Medical Center, New York, NY, 

This study and medical writing support were funded by grants from Exeltis USA Dermatology 
Acknowledgements: The authors would like to thank Tom Prunty, CMPP and Bob Rhoades, PhD of AraMed Strategies for their assistance with medical writing services.


	FC17PosterExeltisHoffmanEffectofEconazole.pdf