Trial Outcomes & Findings for An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot (NCT NCT01110330)
NCT ID: NCT01110330
Last Updated: 2014-04-29
Results Overview
Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
583 participants
Primary outcome timeframe
Week 6
Results posted on
2014-04-29
Participant Flow
All randomized patients (583) received at least one dose of study treatment and were included in the Safety Set. Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary and Secondary Outcome Measures.
Participant milestones
| Measure |
Placebo
A topical white homogenous cream identical in appearance to study drug
|
Nizoral
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Ketoconazole
Ketoconazole 2% cream (formulation F126)
|
|---|---|---|---|
|
Overall Study
STARTED
|
119
|
230
|
234
|
|
Overall Study
Positive Baseline Culture Set
|
56
|
111
|
114
|
|
Overall Study
COMPLETED
|
104
|
207
|
208
|
|
Overall Study
NOT COMPLETED
|
15
|
23
|
26
|
Reasons for withdrawal
| Measure |
Placebo
A topical white homogenous cream identical in appearance to study drug
|
Nizoral
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Ketoconazole
Ketoconazole 2% cream (formulation F126)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
15
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
2
|
|
Overall Study
Other
|
1
|
1
|
1
|
Baseline Characteristics
An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
Baseline characteristics by cohort
| Measure |
Placebo
n=119 Participants
A topical white homogenous cream identical in appearance to study drug
|
Nizoral
n=230 Participants
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Ketoconazole
n=234 Participants
Ketoconazole 2% cream (formulation F126)
|
Total
n=583 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
525 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 14.89 • n=5 Participants
|
45 years
STANDARD_DEVIATION 13.94 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 14.62 • n=5 Participants
|
45 years
STANDARD_DEVIATION 14.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
|
Baseline BMI
|
28.1 kg/m2
STANDARD_DEVIATION 5.81 • n=5 Participants
|
27.9 kg/m2
STANDARD_DEVIATION 4.76 • n=7 Participants
|
28.3 kg/m2
STANDARD_DEVIATION 5.09 • n=5 Participants
|
28.1 kg/m2
STANDARD_DEVIATION 5.11 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary Outcome Measure.
Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.
Outcome measures
| Measure |
Placebo
n=56 Participants
A topical white homogenous cream identical in appearance to study drug
|
Nizoral
n=111 Participants
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Ketoconazole
n=114 Participants
Ketoconazole 2% cream (formulation F126)
|
|---|---|---|---|
|
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6
|
11 participants
|
64 participants
|
64 participants
|
SECONDARY outcome
Timeframe: Week 6Population: Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Secondary Outcome Measure.
Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either 'Completely Cleared' (clearance of all signs and symptoms of Tinea pedis) or 'Marked Improvement' (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.
Outcome measures
| Measure |
Placebo
n=56 Participants
A topical white homogenous cream identical in appearance to study drug
|
Nizoral
n=111 Participants
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Ketoconazole
n=114 Participants
Ketoconazole 2% cream (formulation F126)
|
|---|---|---|---|
|
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6
|
5 participants
|
55 participants
|
50 participants
|
Adverse Events
Ketoconazole
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Nizoral
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketoconazole
n=234 participants at risk
Ketoconazole 2% cream (formulation F126)
|
Nizoral
n=230 participants at risk
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Placebo
n=119 participants at risk
A topical white homogenous cream identical in appearance to study drug
|
|---|---|---|---|
|
Infections and infestations
Anal Abscess
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Infections and infestations
Pneumonia
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Back Disorder
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Salivary Gland Neoplasm
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Renal and urinary disorders
Urinary Retention
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
Other adverse events
| Measure |
Ketoconazole
n=234 participants at risk
Ketoconazole 2% cream (formulation F126)
|
Nizoral
n=230 participants at risk
Ketoconazole 2% cream (formulation F012) (Nizoral)
|
Placebo
n=119 participants at risk
A topical white homogenous cream identical in appearance to study drug
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Eye disorders
Conjunctivitis
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.85%
2/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
3/234
|
0.43%
1/230
|
1.7%
2/119
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Food Poisoning
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Gastrointestinal disorders
Loose Tooth
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Toothache
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
2/234
|
0.00%
0/230
|
0.00%
0/119
|
|
General disorders
Application Site Erythema
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
General disorders
Application Site Pruritus
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
General disorders
Application Site Reaction
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
General disorders
Chest Discomfort
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
General disorders
Influenza Like Illness
|
0.00%
0/234
|
0.43%
1/230
|
0.84%
1/119
|
|
General disorders
Oedema Peripheral
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
General disorders
Pyrexia
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Infections and infestations
Folliculitis
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Gastroenteritis
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Infections and infestations
Gastroenteritis Viral
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Infection
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Influenza
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.85%
2/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
6/234
|
1.3%
3/230
|
2.5%
3/119
|
|
Infections and infestations
Oral Candidiasis
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Oral Herpes
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Pharyngitis
|
0.85%
2/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Infections and infestations
Rhinitis
|
0.85%
2/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Infections and infestations
Tinea Pedis
|
1.3%
3/234
|
2.2%
5/230
|
5.0%
6/119
|
|
Infections and infestations
Tonsillitis
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Tooth Infection
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.1%
5/234
|
0.87%
2/230
|
4.2%
5/119
|
|
Infections and infestations
Urinary Tract Infection
|
0.85%
2/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Infections and infestations
Wound Infection
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Contusion
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Human Bite
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Injury
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Investigations
Biopsy
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/234
|
0.43%
1/230
|
0.84%
1/119
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.85%
2/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.3%
3/234
|
0.87%
2/230
|
2.5%
3/119
|
|
Nervous system disorders
Dizziness
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Nervous system disorders
Headache
|
0.85%
2/234
|
1.3%
3/230
|
1.7%
2/119
|
|
Nervous system disorders
Lethargy
|
0.43%
1/234
|
0.43%
1/230
|
0.84%
1/119
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Nervous system disorders
Sciatica
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Psychiatric disorders
Depression
|
0.00%
0/234
|
0.00%
0/230
|
0.84%
1/119
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.85%
2/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.43%
1/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/234
|
0.87%
2/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/234
|
1.3%
3/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
5/234
|
1.3%
3/230
|
0.84%
1/119
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.85%
2/234
|
0.87%
2/230
|
0.84%
1/119
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.43%
1/234
|
0.43%
1/230
|
0.00%
0/119
|
|
Surgical and medical procedures
Tooth Extraction
|
0.43%
1/234
|
0.00%
0/230
|
0.00%
0/119
|
|
Vascular disorders
Hypertension
|
0.00%
0/234
|
0.43%
1/230
|
0.00%
0/119
|
Additional Information
Director Infectious Diseases
Jan-Cil Switzerland
Phone: 41 41 7673477
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place