Trial Outcomes & Findings for Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis (NCT NCT01433107)

Results Overview

Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

290 participants

Primary outcome timeframe

week 6

Results posted on

2013-12-27

Participant Flow

Study start 27 Aug 2011 end 14 Feb 2012

Each particiapant received a single dose of Terbinafine Film Forming Solution 1% or matching placebo

Participant milestones

Participant milestones
Measure	Terbinafine Drug	Placebo Drug
Overall Study STARTED	145	145
Overall Study COMPLETED	118	128
Overall Study NOT COMPLETED	27	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Terbinafine n=145 Participants Drug	Placebo n=145 Participants Drug	Total n=290 Participants Total of all reporting groups
Age, Continuous	35.27 years STANDARD_DEVIATION 12.805 • n=5 Participants	34.05 years STANDARD_DEVIATION 11.936 • n=7 Participants	34.66 years STANDARD_DEVIATION 12.372 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	46 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	95 Participants n=5 Participants	99 Participants n=7 Participants	194 Participants n=5 Participants

PRIMARY outcome

Timeframe: week 6

Population: Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).

Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18

Outcome measures

Outcome measures
Measure	Terbinafine n=115 Participants Drug	Placebo n=122 Participants Drug
Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)	73 participants	10 participants

SECONDARY outcome

Timeframe: week 6

Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18

Outcome measures

Outcome measures
Measure	Terbinafine n=113 Participants Drug	Placebo n=121 Participants Drug
Total Clinical Signs and Symptoms (S/S) Scores	1.6 units on a scale Interval 1.3 to 2.0	4.7 units on a scale Interval 4.1 to 5.2

SECONDARY outcome

Timeframe: 6 weeks

Population: Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.

Number of Subjects with adverse event

Outcome measures

Outcome measures
Measure	Terbinafine n=146 Participants Drug	Placebo n=144 Participants Drug
Number of Subjects With Adverse Event	9 participants	11 participants

Adverse Events

Terbinafine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Terbinafine n=146 participants at risk Drug	Placebo n=144 participants at risk Drug
General disorders General Disorders	0.00% 0/146 One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.	4.9% 7/144 • Number of events 7 One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.

Additional Information

Clinical Project leader

Novartis

Phone: +41223633111

Results disclosure agreements

Principal investigator is a sponsor employee Preliminary agreement between Novartis Consumer Health and the investigator
Publication restrictions are in place

Restriction type: OTHER