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

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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Cruris; Jock Itch
• Intervention / Treatment: Drug: Placebo; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; placebo	Drug: Placebo; placebo cream applied for up to 4 weeks
Experimental: 1; NAFT-500	Drug: NAFT-500; topical cream application up to 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects	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.	Week 4 post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological Cure and Treatment Effectiveness	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.	Week 4 (two weeks post-treatment)

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Principal Investigator: Lawrence Parish, MD, Paddington Testing Company

Publications and helpful links

General Publications

• Parish LC, Parish JL, Routh HB, Avakian E, Olayinka B, Pappert EJ, Plaum S, Fleischer AB, Hardas B. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. J Drugs Dermatol. 2011 Oct;10(10):1142-7.

Helpful Links

• Naftin Cream 2% product information

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 9, 2008
• First Submitted That Met QC Criteria: September 9, 2008
• First Posted (Estimate): September 10, 2008

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: tinea cruris; jock itch
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatitis; Skin Diseases, Eczematous; Dermatomycoses; Intertrigo; Tinea; Tinea cruris
• Other Study ID Numbers: MRZ 90200/FI/3001