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

Tinea Cruris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750152
• Other study ID #: MRZ 90200/FI/3001
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2008
• Last updated: April 15, 2013
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2012
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Jock Itch
• Tinea
• Tinea Cruris

Intervention

Drug:
• NAFT-500
topical cream application up to 4 weeks
• Placebo
placebo cream applied for up to 4 weeks

Locations

Country	Name	City	State
Puerto Rico	Edwin Camilio Vazquez, MD	Aguas Buenas
Puerto Rico	Medicina General y Cirugia Menor	Cayey
Puerto Rico	Advanced Medical Concepts, PSC	Cidra
Puerto Rico	Manuel Guzman, MD	Humacao
Puerto Rico	Isabel Quijano, MD	Rio Piedras
United States	Radiant Research	Birmingham	Alabama
United States	J&S Studies	College Station	Texas
United States	Research Across America	Dallas	Texas
United States	Haber Dermatology	Euclid	Ohio
United States	Silverton Skin Institute	Grand Blanc	Michigan
United States	Zoe Draelos, MD	High Point	North Carolina
United States	FXM Research	Miami	Florida
United States	FXM Research	Miramar	Florida
United States	Tennesse Clinical Research	Nashville	Tennessee
United States	Tulane Univeristy Health Services Ctr.	New Orleans	Louisiana
United States	Paddington Testing Company	Philadelphia	Pennsylvania
United States	Research Across America	Plano	Texas
United States	Oakwell Clinical Research	San Antonio	Texas
United States	University Clinical Trials	San Diego	California
United States	University of California San Francisco Dept of Dermatology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & 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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No

External Links

•   Naftin Cream 2% product information