Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01289015
First received: January 28, 2011
Last updated: July 26, 2013
Last verified: July 2013

January 28, 2011
July 26, 2013
February 2011
November 2011   (final data collection date for primary outcome measure)
Complete Cure of Interdigital Tinea Pedis [ Time Frame: Visit 4/ Week 6 ] [ Designated as safety issue: No ]

The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.

Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.

Complete cure of interdigital tinea pedis [ Time Frame: Visit 4/ Week 6 ] [ Designated as safety issue: No ]

The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.

Complete cure is defined as:

  1. mycological cure (i.e. negative dermatophyte culture and negative KOH) and
  2. clinical cure (i.e. absence of erythema, scaling and pruritus {scores of 0, each}).
Complete list of historical versions of study NCT01289015 on ClinicalTrials.gov Archive Site
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 [ Time Frame: Visit 4/ Week 6. ] [ Designated as safety issue: No ]

Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).

Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.

Effective treatment of interdigital tinea pedis [ Time Frame: Visit 4/ Week 6. ] [ Designated as safety issue: Yes ]

Effective treatment of interdigital tinea pedis; treatment is defined as mycological cure(negative dermatophyte culture and negative KOH) and clinical success(erythema, scaling and pruritus scores of 0 or 1 {absent or mild}).

Other endpoints: Complete cure, effective treatment, and mycological cure of moccasin tinea pedis at Week 6.

Safety Variables: Type, incidence, severity, timing, and relationship of adverse events (local and systemic)collected at each visit, laboratory tests (Day 1, Week 2,Week 6), and vital signs (Day 1,Week 6).

Not Provided
Not Provided
 
Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Tinea Pedis
  • Drug: NAFT-600 ( naftin 2 % gel )
    Topical; applied once daily for two weeks
  • Drug: Placebo
    Topical; applied once daily for two weeks
  • Experimental: NAFT-600 ( naftin 2 % gel)
    Intervention: Drug: NAFT-600 ( naftin 2 % gel )
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
855
January 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.
  • Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s)).

Exclusion Criteria:

  • Subjects with 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 drugs 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.
  • Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
  • Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.
  • Extremely severe tinea pedis (incapacitating).
  • 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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01289015
MRZ 90200/3015/1
No
Merz Pharmaceuticals, LLC
Merz Pharmaceuticals, LLC
Not Provided
Principal Investigator: Lawrence Parish, MD Paddington Testing Co., Inc.
Merz Pharmaceuticals, LLC
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP