Tinea CrurisPhase 3NCT00750152
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris
A Phase 3 study testing NAFT-500 in people with Tinea Cruris and Jock Itch, run by Merz North America, Inc. at 20 sites in 2 countries.
Trial summary
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinea Cruris, Jock Itch
- What is being tested?
- NAFT-500
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Sep 2008to Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Review and sign a statement of Informed Consent and HIPAA authorization.
- Males or non-pregnant females ≥12 years of age, of any race or sex. Females of childbearing potential must have a negative urine pregnancy test.
- For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- Presence of tinea cruris characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) as confirmed by signs and symptoms.
- KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
- Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
- Subjects must be able to understand the requirements of the study and willing to comply with the study requirements.
Who cannot join
- A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- Subjects with a known hypersensitivity to study medications or their components.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- Uncontrolled diabetes mellitus.
- Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
Show all 16Show fewer
- Current diagnosis of immunocompromising conditions.
- Atopic or contact dermatitis.
- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
- Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study (females who are surgically sterilized or post menopausal for at least 2 years are not considered to be of childbearing potential). For the purposes of this study,acceptable forms of birth control include: oral contraceptives, contraceptive patches/implants, double barrier methods (e.g., use of condom and spermicide), IUD, and abstinence with second acceptable method should subject become sexually active.
- Subjects using the following medications:
- Topical anti-fungal therapy, powders or topical corticosteroids applied within 14 days prior to randomization. Terbinafine, butenafine, and naftifine (topical) within 30 days prior to randomization.
- Oral anti-fungal therapies within 3 months of randomization (8 months for oral terbinafine).
- Systemic antibiotic or corticosteroid treatment within 30 days of randomization.
- Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment.
- Investigational drug/ device within 30 days of randomization
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States15 sites
Radiant Research
Birmingham, Alabama, 35209
J&S Studies
College Station, Texas, 77845
Research Across America
Dallas, Texas, 75234
Haber Dermatology
Euclid, Ohio, 44118
Silverton Skin Institute
Grand Blanc, Michigan, 48439
Zoe Draelos, MD
High Point, North Carolina, 27262
FXM Research
Miami, Florida, 33175
FXM Research
Miramar, Florida, 33027
Tennesse Clinical Research
Nashville, Tennessee, 37215
Tulane Univeristy Health Services Ctr.
New Orleans, Louisiana, 70112
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
Research Across America
Plano, Texas, 75093
Oakwell Clinical Research
San Antonio, Texas, 78218
University Clinical Trials
San Diego, California, 92123
University of California San Francisco Dept of Dermatology
San Francisco, California, 94115
Puerto Rico5 sites
Edwin Camilio Vazquez, MD
Aguas Buenas, 00703
Medicina General y Cirugia Menor
Cayey, 00736
Advanced Medical Concepts, PSC
Cidra, 00739
Manuel Guzman, MD
Humacao, 00791
Isabel Quijano, MD
Rio Piedras, 00921
About this study
Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Cruris
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.
Read the detailed description
To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.
- Conditions
- Tinea Cruris, Jock Itch
- Being tested
- NAFT-500, Placebo
- Keywords
- tinea cruris, jock itch
- Medical subject headings
- Tinea Cruris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFT-500Drug
topical cream application up to 4 weeks
PlaceboDrug
placebo cream applied for up to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | placebo Receives: Drug: Placebo |
| 1 | Experimental | NAFT-500 Receives: Drug: NAFT-500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects
Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.
Measured: Week 4 post-baseline
Secondary outcomes (1)
Mycological Cure and Treatment Effectiveness
Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.
Measured: Week 4 (two weeks post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinea CrurisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Parish, MD, Principal investigator, Paddington Testing Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750152
- Sponsor's protocol ID
- MRZ 90200/FI/3001
- Status last verified
- Oct 2012
- First submitted
- 9 Sep 2008
- Last updated
- 22 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parish LC, Parish JL, Routh HB, Avakian E, Olayinka B, Pappert EJ, Plaum S, Fleischer AB, Hardas B. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. J Drugs Dermatol. 2011 Oct;10(10):1142-7.
PubMed 21968664
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Cruris
- ClinicalTrials.gov ID
- NCT00750152
- Acronym / sponsor ID
- MRZ 90200/FI/3001
- Conditions
- Tinea Cruris, Jock Itch
- Keywords
- tinea cruris, jock itch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 13 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.
Detailed description
To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placeboplacebo |
| 1 | Experimental | Drug: NAFT-500NAFT-500 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Review and sign a statement of Informed Consent and HIPAA authorization.
- Males or non-pregnant females ≥12 years of age, of any race or sex. Females of childbearing potential must have a negative urine pregnancy test.
- For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- Presence of tinea cruris characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) as confirmed by signs and symptoms.
- KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
Key exclusion criteria (16 listed)
- A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- Subjects with a known hypersensitivity to study medications or their components.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| NAFT-500topical cream application up to 4 weeks | Drug | 1 |
| Placeboplacebo cream applied for up to 4 weeks | Drug | 2 |
Primary outcome
Percentage of Subjects
Time frame: Week 4 post-baseline
Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.
1 secondary outcome
Mycological Cure and Treatment Effectiveness
Time frame: Week 4 (two weeks post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21968664Parish LC, Parish JL, Routh HB, Avakian E, Olayinka B, Pappert EJ, Plaum S, Fleischer AB, Hardas B. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. J Drugs Dermatol. 2011 Oct;10(10):1142-7.
- Naftin Cream 2% product informationLink provided by the sponsor.
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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.
Lawrence Parish, MD principal investigator
Paddington Testing Company
20 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 NAFT-500 in people with Tinea Cruris and Jock Itch, run by Merz North America, Inc. at 20 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 16 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects (time frame: Week 4 post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750152, which also lists 1 linked publication.
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 22 Apr 2013.