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

NCT00750152 | Completed Phase 3 Results

• 1 other identifier: MRZ 90200/FI/3001
• Study Type: interventional
• Target: 334
• Locations: 2 countries
• Sites: 20

Brief Summary

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.

Conditions

Tinea Cruris; Jock Itch

Keywords

tinea cruris; jock itch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mycological Cure and Treatment Effectiveness

  Week 4 (two weeks post-treatment)

Study Arms (2)

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

1

EXPERIMENTAL

NAFT-500

Drug: NAFT-500

Interventions

NAFT-500 DRUG

topical cream application up to 4 weeks

1

Placebo DRUG

placebo cream applied for up to 4 weeks

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Review and sign a statement of Informed Consent and HIPAA authorization.
• 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.
• 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).
• 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.
• KOH positive and culture 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.
• Subjects must be able to understand the requirements of the study and willing to comply with the study requirements.

You may not qualify if:

• 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.
• 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 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.
• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (20)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

University of California San Francisco Dept of Dermatology

San Francisco, California, 94115, United States

Location

FXM Research

Miami, Florida, 33175, United States

Location

FXM Research

Miramar, Florida, 33027, United States

Location

Tulane Univeristy Health Services Ctr.

New Orleans, Louisiana, 70112, United States

Location

Silverton Skin Institute

Grand Blanc, Michigan, 48439, United States

Location

Zoe Draelos, MD

High Point, North Carolina, 27262, United States

Location

Haber Dermatology

Euclid, Ohio, 44118, United States

Location

Paddington Testing Company

Philadelphia, Pennsylvania, 19103, United States

Location

Tennesse Clinical Research

Nashville, Tennessee, 37215, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Oakwell Clinical Research

San Antonio, Texas, 78218, United States

Location

Edwin Camilio Vazquez, MD

Aguas Buenas, 00703, Puerto Rico

Location

Medicina General y Cirugia Menor

Cayey, 00736, Puerto Rico

Location

Advanced Medical Concepts, PSC

Cidra, 00739, Puerto Rico

Location

Manuel Guzman, MD

Humacao, 00791, Puerto Rico

Location

Isabel Quijano, MD

Rio Piedras, 00921, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 21968664 RESULT

Related Links

• Naftin Cream 2% product information

MeSH Terms

Conditions

Tinea Cruris

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Intertrigo; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Merz Pharmaceuticals, LLC
• Organization: Merz Pharmaceuticals, LLC

800-334-0514

Study Officials

• Lawrence Parish, MD

  Paddington Testing Company

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: April 22, 2013
• Results First Posted: March 13, 2012

Record last verified: 2012-10

Locations

US (15); PR (5)