Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris

• ClinicalTrials.gov Identifier: NCT01885156
• Recruitment Status: Completed
• First Posted: June 24, 2013
• Last Update Posted: April 15, 2015
• Sponsor: Merz North America, Inc.
• Information provided by (Responsible Party): Merz North America, Inc.

Tracking Information

• First Submitted Date: June 20, 2013
• First Posted Date: June 24, 2013
• Last Update Posted Date: April 15, 2015
• Study Start Date: August 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2013)

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 ]

- Summarization of AEs (local and systemic)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 21, 2013)

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 ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
• Official Title: 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Tinea Cruris
• Jock Itch

Intervention

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

Study Arms

• Placebo Comparator: Placebo Cream
  Topically applied once daily
  Intervention: Drug: Placebo Cream
• Experimental: Naftin 1% Cream
  Topically applied once daily
  Intervention: Drug: Naftin 1% Cream

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2014): 65
• Original Estimated Enrollment (submitted: June 21, 2013): 72
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belize, Dominican Republic, Honduras

Administrative Information

• NCT Number: NCT01885156
• Other Study ID Numbers: MUS 90200_3028_1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Merz North America, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Merz North America, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Stefan Plaum, MD; Merz North America, Inc.

• PRS Account: Merz North America, Inc.
• Verification Date: March 2015