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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01885156
Other study ID # MUS 90200_3028_1
Secondary ID
Status Completed
Phase Phase 3
First received June 20, 2013
Last updated March 26, 2015
Start date August 2013
Est. completion date November 2013

Study information

Verified date March 2015
Source Merz Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- Review and sign statement of Informed Consent and HIPAA authorization.

- Males or non-pregnant females = 12 years of age to 17 years, 11 months, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.

- 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) based on signs and symptoms.

- KOH 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.

- Subject must be able to understand the requirements of the study and willing to comply with the study requirements.

Exclusion Criteria:

- 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.- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.

- 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.

- 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 for at least 2 years are not considered to be of childbearing potential).

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Naftin 1% Cream
Topically applied once a day
Placebo Cream
Topically applied once a day

Locations

Country Name City State
Belize Merz Investigational Site # 501001 Belize City
Belize Merz Investigational Site # 501002 Belize City
Dominican Republic Merz Investigative Site # 180002 San Cristobal
Dominican Republic Merz Investigative Site # 180001 Santo Domingo
Honduras Merz Investigative Site # 504001 San Pedro Sula

Sponsors (1)

Lead Sponsor Collaborator
Merz Pharmaceuticals, LLC

Countries where clinical trial is conducted

Belize,  Dominican Republic,  Honduras, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). - Summarization of AEs (local and systemic) Week 6 Yes
Secondary Efficacy of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH and culture positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). Complete Cure based on:
-Negative mycology results; absence (Grade 0) of erythema, scaling, and pruritis
Other efficacy variables assessed at Week 2, Week 4, and Week 6:
Effective treatment
Mycological cure
Clinical Success
Clinical Cure
Investigator Global Assessment
Subject Satisfaction Assessment
Week 6 No
See also
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Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT01342315 - Topical Antifungal Treatment for Tinea Cruris Phase 3
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Completed NCT02394340 - Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris Phase 4
Completed NCT05363449 - Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis Phase 1
Completed NCT02767271 - Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris Phase 4
Not yet recruiting NCT01105013 - Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Phase 3