Tinea PedisPhase 3NCT04203342
A Therapeutic Equivalence Study of Ketoconazole Cream 2%
A Phase 3 study testing Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) and Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA) in people with Tinea Pedis, run by Douglas Pharmaceuticals America Ltd at 3 sites in 2 countries.
Trial summary
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) and Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 682 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Dec 2019to 13 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male or non-pregnant, non-lactating female, 18 years of age or older
- Signed ICF meeting all criteria of current FDA regulations
- Female subject of childbearing potential must NOT be pregnant or lactating at Visit 1 (negative urine pregnancy test)
- Female subject of childbearing potential must agree to use of reliable method of contraception.
- Clinical diagnosis of tinea pedis predominantly in interdigital spaces
- Tinea pedis confirmed at baseline by positive KOH wet mount.
- Sum of clinical signs and symptoms score of target lesion at least 4; in addition target lesion must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritis or scaling.
Who cannot join
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- history of, or current psoriasis, lichen planus, or contact dermatitis involving the feet within the previous 12 months.
- history of dermatophyte infections with a lack of response to antifungal systemic or topical therapy (recurrent tinea pedis [i.e.more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
- history of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
- confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- current uncontrolled diabetes.
Show all 18Show fewer
- presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the subject's tinea pedis.
- known history of or current impaired wound healing, presence of peripheral vascular disease and/or trophic changes of the lower limbs to an extent that, in the opinion of the Investigator would make the subject unsuitable for the study or compromise subject's safety.
- Signficant history or current evidence of chronic infectious disease, system disorder, organ disorder, immunosuppression (due to disease or therapy, including history of organ transplant), or other medical condition that, in the opinion of the Investigator, would place the subject at undue risk by participating or compromise the integrity of the study data.
- Use of antipruritics, including antihistamines, within 72 hours prior to Visit 1.
- Use of topical corticosteroids, topical antibiotics or topical antifungal therapy (e.g. clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.
- Use of systemic (e.g. oral or injectable) antibiotics, systemic antifungal therapy, or systemic corticosteroids within 30 days before Visit 1. The use of intranasal, inhaled or ophthalmic corticosteroids for acute or chronic conditions (e.g. allergic conjunctivitis, asthma/COPD maintenance) is acceptable to the extent that, in the opinion of the Investigator, does not compromise safety of subject or integrity of the data.
- Use of oral terbinafine or itraconazole within 2 months before Visit 1.
- Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
- Receipt of any drug as part of a research study within 30 days before Visit 1.
- Previous participation in this study.
- Employee of the Investigator or research centre or their immediate family members.
- Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Moore Clinical Research
Brandon, Florida, 33511
Moore Clinical Reseach
Tampa, Florida, 33609
Belize1 site
FXM Research International
Belize City
About this study
Official title: A Randomized,Double-blind,Vehicle-controlled, Parallel-design,Multiple-site Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Douglas Pharmaceuticals America Ltd) to Ketoconazole Cream 2% (Teva Pharmaceuticals USA Inc.) in the Treatment of Tinea Pedis.
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.
Read the detailed description
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.
- Conditions
- Tinea Pedis
- Being tested
- Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.), Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA), Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)
- Keywords
- Tinea pedis, Ketoconazole
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)Drug
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.
Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)Drug
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.
Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketoconazole 2% cream (Douglas Pharmaceuticals America Ltd.) | Experimental | Subject will be randomized to either test product/active comparator/placebo comparator. Test product is Ketoconazole 2% cream manufactured by Douglas Pharmaceuticals America Ltd. Receives: Drug: Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) |
| Ketoconazole 2% cream (Teva Pharmaceuticals USA) | Active comparator | Subject will be randomized to either test product/active comparator/placebo comparator. Active comparator is Ketaconazole 2% cream manufactured by Teva Pharmaceuticals USA. Receives: Drug: Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA) |
| Placebo (Douglas Pharmaceuticals America Ltd.) | Placebo comparator | Subject will be randomized to either test product/active comparator/placebo comparator. Placebo comparator is manufactured by Douglas Pharmaceuticals America Ltd. Receives: Drug: Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks post-treatment (Day 56)
Secondary outcomes (2)
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)
- Mild (slight)
- moderate (definitely present)
- Severe (Marked, intense).
The following signs and symptoms will be rated:
Signs = fissuring/cracking, erythema, maceration, and scaling Symptoms = pruritis and burning/stinging
Measured: 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.
Measured: 2 weeks post-treatment (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start11 Dec 2019
- Primary completion28 May 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Pharmaceuticals America Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services, ACM Global Laboratories
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203342
- Sponsor's protocol ID
- 71864602
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Double-blind,Vehicle-controlled, Parallel-design,Multiple-site Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Douglas Pharmaceuticals America Ltd) to Ketoconazole Cream 2% (Teva Pharmaceuticals USA Inc.) in the Treatment of Tinea Pedis.
- ClinicalTrials.gov ID
- NCT04203342
- Acronym / sponsor ID
- 71864602
- Conditions
- Tinea Pedis
- Keywords
- Tinea pedis, Ketoconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Douglas Pharmaceuticals America LtdIndustry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services, ACM Global Laboratories
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketoconazole 2% cream (Douglas Pharmaceuticals America Ltd.) | Experimental | Drug: Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)Subject will be randomized to either test product/active comparator/placebo comparator. Test product is Ketoconazole 2% cream manufactured by Douglas Pharmaceuticals America Ltd. |
| Ketoconazole 2% cream (Teva Pharmaceuticals USA) | Active comparator | Drug: Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)Subject will be randomized to either test product/active comparator/placebo comparator. Active comparator is Ketaconazole 2% cream manufactured by Teva Pharmaceuticals USA. |
| Placebo (Douglas Pharmaceuticals America Ltd.) | Placebo comparator | Drug: Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)Subject will be randomized to either test product/active comparator/placebo comparator. Placebo comparator is manufactured by Douglas Pharmaceuticals America Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male or non-pregnant, non-lactating female, 18 years of age or older
- Signed ICF meeting all criteria of current FDA regulations
- Female subject of childbearing potential must NOT be pregnant or lactating at Visit 1 (negative urine pregnancy test)
- Female subject of childbearing potential must agree to use of reliable method of contraception.
- Clinical diagnosis of tinea pedis predominantly in interdigital spaces
Key exclusion criteria (18 listed)
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- history of, or current psoriasis, lichen planus, or contact dermatitis involving the feet within the previous 12 months.
- history of dermatophyte infections with a lack of response to antifungal systemic or topical therapy (recurrent tinea pedis [i.e.more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
- history of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
- confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Ketoconazole 2% Cream (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. | Drug | Ketoconazole 2% cream (Douglas Pharmaceuticals America Ltd.) |
| Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)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. | Drug | Ketoconazole 2% cream (Teva Pharmaceuticals USA) |
| Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)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. | Drug | Placebo (Douglas Pharmaceuticals America Ltd.) |
Primary outcome
Therapeutic cure of tinea pedis
Time frame: 2 weeks post-treatment (Day 56)
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.
2 secondary outcomes
Clinical cure of tinea pedis
Time frame: 2 weeks post-treatment (Day 56)
Mycological cure of tinea pedis
Time frame: 2 weeks post-treatment (Day 56)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) and Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA) in people with Tinea Pedis, run by Douglas Pharmaceuticals America Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Belize. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic cure of tinea pedis (time frame: 2 weeks post-treatment (Day 56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.