A Phase 3 interventional study of Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) and Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA) in Tinea Pedis, sponsored by Douglas Pharmaceuticals America Ltd. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-06.
Sponsored by Douglas Pharmaceuticals America Ltd · Phase 3, Interventional, and Treatment
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.
A randomized, double-blind, vehicle-controlled, parallel-design, multiple-site study to evaluate the clinical (therapeutic) effet of a generic Ketoconazole Cream 2% (Douglas Pharmaceuticals America Ltd) compared with the reference standard Ketoconazole Cream 2% (Teva Pharmaceuticals USA Inc) in subjects with a microbiologically-confirmed, clinical diagnosis of tinea pedis. Approximately 675 subjects, male or female, 18 years or older, will be enrolled.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 682 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →This is the only study on the registry with Douglas Pharmaceuticals America Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject will be randomized to either test product/active comparator/placebo comparator. Test product is Ketoconazole 2% cream manufactured by Douglas Pharmaceuticals America Ltd.
Drug: Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)
Subject will be randomized to either test product/active comparator/placebo comparator. Active comparator is Ketaconazole 2% cream manufactured by Teva Pharmaceuticals USA.
Drug: Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)
Subject will be randomized to either test product/active comparator/placebo comparator. Placebo comparator is manufactured by Douglas Pharmaceuticals America Ltd.
Drug: Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)
Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
Topical placebo to treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
Therapeutic cure of tinea pedis
The proportion of subjects in each treatment group with a Therapeutic Cure of tinea pedis at the test-of-cure visit conducted 2 weeks after the end of treatment (Day 56 +/- 4). Therapeutic cure is defined as having both a clinical and mycological cure of tinea pedis.
Time frame: 2 weeks post-treatment (Day 56)
Clinical cure of tinea pedis
The proportion of subjects in each treatment group with a Clinical Cure at Day 56 +/- 4. Clinical Cure is defined as a total severity score of \</= 2, with no individual severity score of \>1. This is calculated using The Clinical Signs and Symptoms of Tinea Pedis rated by the Investigator using a standardized rating scale as follows: 0=none (complete absence of any sign or symptom) 1. Mild (slight) 2. moderate (definitely present) 3. Severe (Marked, intense). The following signs and symptoms will be rated: Signs = fissuring/cracking, erythema, maceration, and scaling Symptoms = pruritis and burning/stinging
Time frame: 2 weeks post-treatment (Day 56)
Mycological cure of tinea pedis
The proportion of subjects in each treatment group with a Mycological Cure of tinea pedis at Day 56 +/- 4. Mycological Cure is defined as having a negative KOH test AND a negative fungal culture.
Time frame: 2 weeks post-treatment (Day 56)
Ran from Dec 2019 to primary completion in May 2020, 5 months.
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Studies of the drug tested here: Ketoconazole