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Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris
This study is currently recruiting participants.
Verified by Merz Pharmaceuticals, LLC, October 2008
Sponsored by: Merz Pharmaceuticals, LLC
Information provided by: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00750152
  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 III

MedlinePlus related topics: Itching Tinea Infections
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • the percentage of subjects at the 2 week time point post treatment with complete cure defined as negative mycology results from the central laboratory (dermatophyte culture, KOH and Physicians Global Evaluation score of 1). [ Time Frame: two weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mycological Cure;Clinical Cure;Clinical Success;Physicians Global Evaluation; Subject Satisfaction Assessment [ Time Frame: two weeks post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Placebo Comparator
placebo
Drug: Placebo
placebo cream applied for up tp 4 weeks
1: Experimental
NAFT-500
Drug: NAFT-500
topical cream application up to 4 weeks

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750152

Contacts
Contact: Rebecca Madura 704-602-6702 rmadura@pharmanet.com

Locations
United States, Alabama
Radiant Research Recruiting
Birmingham, Alabama, United States, 35209
Contact: Spencer Boddy     205-870-8803     spencerboddy@radiantresearch.com    
Principal Investigator: Jolynne Herzog, MD            
United States, California
University of California San Francisco Dept of Dermatology Recruiting
San Francisco, California, United States, 94115
Contact: Sarah Hiliker     415-885-3636     hilikers@derm.ucsf.edu    
Principal Investigator: Raza Aly, PhD            
United States, Florida
FXM Research Recruiting
Miami, Florida, United States, 33175
Contact: Francisco Moncada     305-220-5222     Francisco.moncada@fxmresearch.com    
Principal Investigator: Hector Wiltz, MD            
FXM Research Recruiting
Miramar, Florida, United States, 33027
Contact: Francisco Moncada     954-430-1097     Francisco.moncado@fxmresearch.com    
Principal Investigator: Francisco Flores, MD            
United States, Louisiana
Tulane Univeristy Health Services Ctr. Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Edward Coleman     504-988-5135     ecoleman@tulane.edu    
Principal Investigator: Erin Boh, MD            
United States, Michigan
Silverton Skin Institute Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Elizabeth Niec     810-606-7500     e_niec@hotmail.com    
Principal Investigator: Kimbell Silverton, DO            
United States, North Carolina
Zoe Draelos, MD Recruiting
High Point, North Carolina, United States, 27262
Contact: Christine Foster     336-841-2040     dcs@northstate.net    
Principal Investigator: Zoe Draelos, MD            
United States, Ohio
Haber Dermatology Recruiting
Euclid, Ohio, United States, 44118
Contact: Janet Cohen     216-932-5200     universityhrc@aol.com    
Principal Investigator: Robert Haber, MD            
United States, Pennsylvania
Paddington Testing Company Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Hirak Routh     215-563-7330     hirakbrouth@yahoo.com    
Principal Investigator: Lawrence Parish, MD            
United States, Texas
Research Across America Recruiting
Plano, Texas, United States, 75093
Contact: Enrique Echaniz     972-241-1222     eechaniz@researchacrossamerica.com    
Principal Investigator: Jeffrey Adelglass, MD            
J&S Studies Recruiting
College Station, Texas, United States, 77845
Contact: Jeremy Scott     979-774-5933     jscott@js-studies.com    
Principal Investigator: Terry Jones, MD            
Oakwell Clinical Research Recruiting
San Antonio, Texas, United States, 78218
Contact: Raul Corpus     210-477-1151     rcorpus@oakwellclinical.com    
Principal Investigator: David Sandercock, DO            
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Lawrence Parish, MD Paddington Testing Company
  More Information

Responsible Party: Merz Pharmaceuticals, LLC ( Clinical Project Manager )
Study ID Numbers: MRZ 90200/FI/3001
Study First Received: September 9, 2008
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00750152  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Pruritus
Mycoses
Skin Diseases, Infectious
Skin Diseases
Tinea
Dermatomycoses

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 16, 2009