Jock Itch, Tinea Cruris
Conditions
Keywords
tinea cruris, jock itch
Brief 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.
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.
Interventions
DRUGNAFT-500
topical cream application up to 4 weeks
DRUGPlacebo
placebo cream applied for up to 4 weeks
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Review and sign a statement of Informed Consent and HIPAA authorization. 2. 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. 3. 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). 4. 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. 5. KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity. 6. Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations. 7. Subjects must be able to understand the requirements of the study and willing to comply with the study requirements.
Exclusion criteria
1. A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months. 2. 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. 3. Subjects with a known hypersensitivity to study medications or their components. 4. Subjects who have a recent history or who are currently known to abuse alcohol or drugs. 5. Uncontrolled diabetes mellitus. 6. Hemodialysis or chronic ambulatory peritoneal dialysis therapy. 7. Current diagnosis of immunocompromising conditions. 8. Atopic or contact dermatitis. 9. Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection. 10. 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. 11. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycological Cure and Treatment Effectiveness | Week 4 (two weeks post-treatment) | 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. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAFT-500 Naftin 2% cream applied daily for 2 weeks | 166 |
| Placebo-2wks Placebo cream applied daily for 2 weeks | 168 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 8 | 13 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Other | 7 | 8 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Termination by sponsor | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | NAFT-500 | Placebo-2wks | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical >=65 years | 23 Participants | 19 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants | 149 Participants | 288 Participants |
| Age Continuous | 47.2 years STANDARD_DEVIATION 15.54 | 46.2 years STANDARD_DEVIATION 14.53 | 46.7 years STANDARD_DEVIATION 15.03 |
| Region of Enrollment Puerto Rico | 54 participants | 55 participants | 109 participants |
| Region of Enrollment United States | 112 participants | 113 participants | 225 participants |
| Sex: Female, Male Female | 22 Participants | 30 Participants | 52 Participants |
| Sex: Female, Male Male | 144 Participants | 138 Participants | 282 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 166 | 10 / 168 |
| serious Total, serious adverse events | 0 / 166 | 0 / 168 |
Outcome results
Primary
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.
Time frame: Week 4 post-baseline
Population: The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAFT-500 | Percentage of Subjects | 25.3 percentage of subjects with complete cur |
| Placebo-2wks | Percentage of Subjects | 2.8 percentage of subjects with complete cur |
Comparison: In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~* H0: p1 \<= p0~* Ha: p1 \> p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively.p-value: 0.025Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Week 4 (two weeks post-treatment)
Population: This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NAFT-500 | Mycological Cure and Treatment Effectiveness | Mycological Cure (MC) | 72.0 percentage of subjects |
| NAFT-500 | Mycological Cure and Treatment Effectiveness | Treatment Effectiveness (TE) | 60.0 percentage of subjects |
| Placebo-2wks | Mycological Cure and Treatment Effectiveness | Treatment Effectiveness (TE) | 9.9 percentage of subjects |
| Placebo-2wks | Mycological Cure and Treatment Effectiveness | Mycological Cure (MC) | 15.5 percentage of subjects |