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Trial record 31 of 32 for:    Clotrimazole AND day

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119742
Recruitment Status : Terminated (Insufficient number of baseline eligible patient)
First Posted : May 10, 2010
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Interdigital Tinea Pedis Drug: Butenafine Hydrochloride 1% Drug: Butenafine Hydrochloride 1% B Drug: Vehicle A Drug: Vehicle B Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Butenafine Hydrochloride 1% A
Drug: Butenafine Hydrochloride 1%
Twice daily application for 7 days

Experimental: Butenafine Hydrochloride 1% B
Drug: Butenafine Hydrochloride 1% B
Twice daily application for 7 days

Active Comparator: Butenafine Hydrochloride 1%
Drug: Butenafine Hydrochloride 1%
Twice daily application for 7 days
Other Name: Lotrimin Ultra Cream

Placebo Comparator: Vehicle A
Drug: Vehicle A
Twice daily application for 7 days

Placebo Comparator: Vehicle B
Drug: Vehicle B
Twice daily application for 7 days

Primary Outcome Measures :
  1. Therapeutic Cure [ Time Frame: 42 Days ]
    Patients with clinical cure and mycologic cure are considered therapeutic cures.

Secondary Outcome Measures :
  1. Clinical Cure [ Time Frame: 42 days ]
    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.

  2. Mycologic Cure [ Time Frame: 42 Days ]
    Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Taro Pharmaceuticals USA Identifier: NCT01119742     History of Changes
Other Study ID Numbers: BTNF-0909
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Taro Pharmaceuticals USA:
Tinea Pedis
Additional relevant MeSH terms:
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Tinea Pedis
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Skin Manifestations
Signs and Symptoms
Antifungal Agents
Anti-Infective Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors