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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01885156
First received: June 20, 2013
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Tinea Cruris
Jock Itch
Drug: Naftin 1% Cream
Drug: Placebo Cream
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    - Summarization of AEs (local and systemic)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Enrollment: 65
Study Start Date: August 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Cream
Topically applied once daily
Drug: Placebo Cream
Topically applied once a day
Experimental: Naftin 1% Cream
Topically applied once daily
Drug: Naftin 1% Cream
Topically applied once a day

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885156

Locations
Belize
Merz Investigational Site # 501001
Belize City, Belize
Merz Investigational Site # 501002
Belize City, Belize
Dominican Republic
Merz Investigative Site # 180002
San Cristobal, Dominican Republic
Merz Investigative Site # 180001
Santo Domingo, Dominican Republic
Honduras
Merz Investigative Site # 504001
San Pedro Sula, Honduras
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Study Director: Stefan Plaum, MD Merz Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01885156     History of Changes
Other Study ID Numbers: MUS 90200_3028_1
Study First Received: June 20, 2013
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tinea
Dermatomycoses
Infection
Mycoses
Skin Diseases
Skin Diseases, Infectious
Naftifine
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014