Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00750152
First received: September 9, 2008
Last updated: April 15, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Tinea Cruris
Jock Itch
Drug: NAFT-500
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Cruris

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Percentage of Subjects [ Time Frame: Week 4 post-baseline ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mycological Cure and Treatment Effectiveness [ Time Frame: Week 4 (two weeks post-treatment) ] [ Designated as safety issue: No ]
    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.


Enrollment: 334
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
placebo
Drug: Placebo
placebo cream applied for up to 4 weeks
Other Name: placebo
Experimental: 1
NAFT-500
Drug: NAFT-500
topical cream application up to 4 weeks
Other Name: NAFT-500

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00750152

Locations
United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
United States, California
University Clinical Trials
San Diego, California, United States, 92123
University of California San Francisco Dept of Dermatology
San Francisco, California, United States, 94115
United States, Florida
FXM Research
Miami, Florida, United States, 33175
FXM Research
Miramar, Florida, United States, 33027
United States, Louisiana
Tulane Univeristy Health Services Ctr.
New Orleans, Louisiana, United States, 70112
United States, Michigan
Silverton Skin Institute
Grand Blanc, Michigan, United States, 48439
United States, North Carolina
Zoe Draelos, MD
High Point, North Carolina, United States, 27262
United States, Ohio
Haber Dermatology
Euclid, Ohio, United States, 44118
United States, Pennsylvania
Paddington Testing Company
Philadelphia, Pennsylvania, United States, 19103
United States, Tennessee
Tennesse Clinical Research
Nashville, Tennessee, United States, 37215
United States, Texas
J&S Studies
College Station, Texas, United States, 77845
Research Across America
Dallas, Texas, United States, 75234
Research Across America
Plano, Texas, United States, 75093
Oakwell Clinical Research
San Antonio, Texas, United States, 78218
Puerto Rico
Edwin Camilio Vazquez, MD
Aguas Buenas, Puerto Rico, 00703
Medicina General y Cirugia Menor
Cayey, Puerto Rico, 00736
Advanced Medical Concepts, PSC
Cidra, Puerto Rico, 00739
Manuel Guzman, MD
Humacao, Puerto Rico, 00791
Isabel Quijano, MD
Rio Piedras, Puerto Rico, 00921
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Lawrence Parish, MD Paddington Testing Company
  More Information

Additional Information:
Publications:
Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00750152     History of Changes
Other Study ID Numbers: MRZ 90200/FI/3001
Study First Received: September 9, 2008
Results First Received: February 8, 2012
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merz Pharmaceuticals, LLC:
tinea cruris
jock itch

Additional relevant MeSH terms:
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014