A Phase 3 interventional study of Placebo cream and Ketoconazole 2% cream (formulation F012) (Nizoral) in Tinea Pedis, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Terminated at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if a new formulation of ketoconazole 2% cream is as effective as a current formulation of ketoconazole 2% cream (Nizoral) compared with placebo in treating patients with Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus.
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned treatment), multicentre study in Poland and the United Kingdom designed to assess the mycological (fungal) cure rate and clinical efficacy of a new formulation of ketoconazole 2% cream (F126) with the current formulation of ketoconazole 2% cream (Nizoral) (F012) compared with placebo cream in patients with symptomatic uncomplicated interdigital (between the toes) Tinea pedis, a skin infection commonly known as "athlete's foot" that is caused by a kind of mold called a fungus. Approximately 548 patients who have symptomatic uncomplicated interdigital Tinea pedis confirmed by positive potassium hydroxide (KOH) microscopy (examination using a microscope) and mycological (fungal) culture will be randomized to receive 1 of 2 formulations of ketoconazole 2% cream (formulation F012 or F126) or placebo cream. There will be 4 study visits during the study. At Visit 1 (baseline), patients will sign the informed consent and be assessed for mycological and clinical signs and symptoms of Tinea pedis. Baseline demographics (age, race, etc), medical history and medication (s) that the patient is currently taking will be recorded. Patients will be issued with a tube of the cream and instructed to apply the cream sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks according to protocol-specified guidelines. During the 4-week treatment period patients will return to the study every 2 weeks to be assessed for clinical signs and symptoms. After the 4-week treatment period, patients will continue participation in the study for an additional 2 weeks without medication. Patients will return then return to the study center for a final visit (Visit 4, Week 6) at which time skin scrapings will be sampled from interdigital spaces on both feet for KOH microscopy and mycological culture. The primary efficacy endpoint is to determine whether a new formulation of ketoconazole 2% cream is equivalent (or as effective) as the current formulation of ketoconazole 2% cream (Nizoral) compared to a placebo cream in achieving a mycological cure (defined as negative KOH microscopy and negative mycological culture) following 4 weeks of treatment. The primary outcome measure in the study is a mycological cure (defined as negative KOH microscopy and negative mycological culture) at week 6. Patients will be monitored for safety (occurrence of adverse events, use of concomitant medications, and reasons for premature discontinuation from the study) from Visit 1 through Visit 4 (Week 6 or time of early termination from study). Patients will be provided with up to two 15g tubes of ketoconazole cream (formulation F126 or F012) or matching placebo cream and be instructed to apply cream sparingly to affected areas of the feet once daily at night or in the evening for 4 weeks according to protocol specified guidelines.
88 studies on the registry are indexed under Tinea; 6 are open to participants now.
This study's enrollment of 583 is above the median of 137 across 82 interventional studies indexed under Tinea.
Browse Tinea studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Exclusion Criteria:
ketoconazole 2% cream (formulation F126) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.
Drug: Ketoconazole 2% cream (formulation F126)
ketoconazole 2% cream (formulation F012) (Nizoral) A topical white homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.
Drug: Ketoconazole 2% cream (formulation F012) (Nizoral)
Placebo cream A topical white homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet) once daily (at night or in the evenings) for a total of 4 weeks.
Drug: Placebo cream
A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6
Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.
Time frame: Week 6
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6
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.
Time frame: Week 6
| Milestone | Placebo | Nizoral | Ketoconazole |
|---|---|---|---|
| Started | 119 | 230 | 234 |
| Positive baseline culture set | 56 | 111 | 114 |
| Completed | 104 | 207 | 208 |
| Not completed | 15 | 23 | 26 |
| Withdrew: Adverse event | 0 | 4 | 3 |
| Withdrew: Lack of efficacy | 3 | 1 | 1 |
| Withdrew: Lost to follow-up | 9 | 10 | 15 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Protocol violation | 2 | 0 | 4 |
| Withdrew: Withdrawal by subject | 0 | 6 | 2 |
| Withdrew: Other | 1 | 1 | 1 |
Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.
| participants | Placebo | Nizoral | Ketoconazole |
|---|---|---|---|
| The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6 | 11 | 64 | 64 |
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.
| participants | Placebo | Nizoral | Ketoconazole |
|---|---|---|---|
| The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6 | 5 | 55 | 50 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketoconazole | — | 2/234 (0.9%) | 55/234 (23.5%) |
| Nizoral | — | 5/230 (2.2%) | 50/230 (21.7%) |
| Placebo | — | 2/119 (1.7%) | 28/119 (23.5%) |
| Event | Ketoconazole | Nizoral | Placebo |
|---|---|---|---|
| Anal AbscessInfections and infestations | 0/234 | 0/230 | 1/119 |
| Transient Ischaemic AttackNervous system disorders | 0/234 | 0/230 | 1/119 |
| PneumoniaInfections and infestations | 0/234 | 1/230 | 0/119 |
| Facial Bones FractureInjury, poisoning and procedural complications | 0/234 | 1/230 | 0/119 |
| Back DisorderMusculoskeletal and connective tissue disorders | 0/234 | 1/230 | 0/119 |
| Benign Salivary Gland NeoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/234 | 1/230 | 0/119 |
| Renal ColicRenal and urinary disorders | 0/234 | 1/230 | 0/119 |
| Joint SwellingMusculoskeletal and connective tissue disorders | 1/234 | 0/230 | 0/119 |
| Urinary RetentionRenal and urinary disorders | 1/234 | 0/230 | 0/119 |
| Event | Ketoconazole | Nizoral | Placebo |
|---|---|---|---|
| Tinea PedisInfections and infestations | 3/234 | 5/230 | 6/119 |
| Upper Respiratory Tract InfectionInfections and infestations | 5/234 | 2/230 | 5/119 |
| NasopharyngitisInfections and infestations | 6/234 | 3/230 | 3/119 |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 3/234 | 2/230 | 3/119 |
| PruritusSkin and subcutaneous tissue disorders | 5/234 | 3/230 | 1/119 |
| DiarrhoeaGastrointestinal disorders | 3/234 | 1/230 | 2/119 |
| HeadacheNervous system disorders | 2/234 | 3/230 | 2/119 |
| ErythemaSkin and subcutaneous tissue disorders | 0/234 | 3/230 | 0/119 |
| DyspepsiaGastrointestinal disorders | 0/234 | 2/230 | 0/119 |
| Lower Respiratory Tract InfectionInfections and infestations | 2/234 | 2/230 | 0/119 |
| Age, Categorical(Participants) | Placebo | Nizoral | Ketoconazole | Total |
|---|---|---|---|---|
| <=18 years | 1 | 2 | 0 | 3 |
| Between 18 and 65 years | 109 | 207 | 209 | 525 |
| >=65 years | 9 | 21 | 25 | 55 |
| Age, Continuous(years) | Placebo | Nizoral | Ketoconazole | Total |
|---|---|---|---|---|
| Mean | 43.2 ± 14.89 | 45 ± 13.94 | 45.9 ± 14.62 | 45 ± 14.42 |
| Sex: Female, Male(Participants) | Placebo | Nizoral | Ketoconazole | Total |
|---|---|---|---|---|
| Female | 29 | 71 | 61 | 161 |
| Male | 90 | 159 | 173 | 422 |
| Baseline BMI(kg/m2) | Placebo | Nizoral | Ketoconazole | Total |
|---|---|---|---|---|
| Mean | 28.1 ± 5.81 | 27.9 ± 4.76 | 28.3 ± 5.09 | 28.1 ± 5.11 |
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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