Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis (BNF-0909)

This study has been terminated.
(Insufficient number of baseline eligible patient)
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01119742
First received: May 6, 2010
Last updated: May 5, 2014
Last verified: May 2014

May 6, 2010
May 5, 2014
July 2010
March 2011   (final data collection date for primary outcome measure)
Therapeutic Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
Patients with clinical cure and mycologic cure are considered therapeutic cures.
Same as current
Complete list of historical versions of study NCT01119742 on ClinicalTrials.gov Archive Site
  • Clinical Cure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Patient will be considered a "clincal cure" if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2.
  • Mycologic Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
    Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.
Same as current
Not Provided
Not Provided
 
Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream in Patients With Interdigital Tinea Pedis

To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Interdigital Tinea Pedis
  • Drug: Butenafine Hydrochloride 1%
    Twice daily application for 7 days
  • Drug: Butenafine Hydrochloride 1% B
    Twice daily application for 7 days
  • Drug: Butenafine Hydrochloride 1%
    Twice daily application for 7 days
    Other Name: Lotrimin Ultra Cream
  • Drug: Vehicle A
    Twice daily application for 7 days
  • Drug: Vehicle B
    Twice daily application for 7 days
  • Experimental: Butenafine Hydrochloride 1% A
    1
    Intervention: Drug: Butenafine Hydrochloride 1%
  • Experimental: Butenafine Hydrochloride 1% B
    2
    Intervention: Drug: Butenafine Hydrochloride 1% B
  • Active Comparator: Butenafine Hydrochloride 1%
    3
    Intervention: Drug: Butenafine Hydrochloride 1%
  • Placebo Comparator: Vehicle A
    4
    Intervention: Drug: Vehicle A
  • Placebo Comparator: Vehicle B
    5
    Intervention: Drug: Vehicle B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
428
July 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or non-pregnant, non lactating females 18 years of age or older.
  2. Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
  3. If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
  4. A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling
  5. A confirmed clinical diagnosis of interdigital tinea pedis.
  6. The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination (potassium hydroxide mount preparation).
  7. Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum.

Exclusion Criteria:

  1. Use of any of the following within the indicated timeline:

    • Oral or injectable steroids within four weeks of the study start.
    • Any oral anti-fungals within 4 weeks of the study start.
    • Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
    • Any prescription or OTC topical antifungal on the feet within two weeks prior to study entry.
    • Use of any antihistamines within 72 hours of the study start.
  2. Any known hypersensitivity to butenafine or other antifungal agents.
  3. Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigators evaluation of tinea pedis.
  4. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01119742
BTNF-0909
No
Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
Not Provided
Not Provided
Taro Pharmaceuticals USA
May 2014

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