- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01885156
Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
March 26, 2015 updated by: Merz North America, Inc.
A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belize City, Belize
- Merz Investigational Site # 501001
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Belize City, Belize
- Merz Investigational Site # 501002
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San Cristobal, Dominican Republic
- Merz Investigative Site # 180002
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Santo Domingo, Dominican Republic
- Merz Investigative Site # 180001
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San Pedro Sula, Honduras
- Merz Investigative Site # 504001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo Cream
Topically applied once daily
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Topically applied once a day
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Experimental: Naftin 1% Cream
Topically applied once daily
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Topically applied once a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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).
Time Frame: Week 6
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- Summarization of AEs (local and systemic)
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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).
Time Frame: Week 6
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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:
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Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stefan Plaum, MD, Merz North America, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
June 21, 2013
First Posted (Estimate)
June 24, 2013
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUS 90200_3028_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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