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:
Taro Pharmaceuticals USA
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01119742
First received: May 6, 2010
Last updated: January 19, 2012
Last verified: January 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Interdigital Tinea Pedis |
Drug: Butenafine Hydrochloride 1% Drug: Butenafine Hydrochloride 1% B Drug: Vehicle A Drug: Vehicle B |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Taro Pharmaceuticals USA:
Primary Outcome Measures:
- Therapeutic Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]Patients with clinical cure and mycologic cure are considered therapeutic cures.
Secondary Outcome Measures:
- 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.
| Enrollment: | 428 |
| Study Start Date: | July 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Butenafine Hydrochloride 1% A
1
|
Drug: Butenafine Hydrochloride 1%
Twice daily application for 7 days
|
|
Experimental: Butenafine Hydrochloride 1% B
2
|
Drug: Butenafine Hydrochloride 1% B
Twice daily application for 7 days
|
|
Active Comparator: Butenafine Hydrochloride 1%
3
|
Drug: Butenafine Hydrochloride 1%
Twice daily application for 7 days
Other Name: Lotrimin Ultra Cream
|
|
Placebo Comparator: Vehicle A
4
|
Drug: Vehicle A
Twice daily application for 7 days
|
|
Placebo Comparator: Vehicle B
5
|
Drug: Vehicle B
Twice daily application for 7 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or non-pregnant, non lactating females 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
- If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
- 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
- A confirmed clinical diagnosis of interdigital tinea pedis.
- 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).
- 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:
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.
- Any known hypersensitivity to butenafine or other antifungal agents.
- 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.
- Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119742
Locations
| India | |
| KBN Institute of Medical Sciences | |
| Gulbarga, Karnataka, India, 585 101 | |
| Drug Monitoring Research Institute Pvt. Ltd., | |
| Mumbai, Maharashtra, India., India, 400705 | |
| Radiance Skin Clinic | |
| Nagpur, Maharashtra,, India, 440001 | |
| Pooja Clinic | |
| Alibag, Maharashtra, India, 402201 | |
| CUTIZ | |
| Mumbai, Maharashtra, India, 400080 | |
| Dr. Sachin Patel Clinic | |
| Mumbai, Maharashtra, India, 400 077 | |
| Skin Care Clinic | |
| Mumbai, Maharashtra, India, 400080 | |
| N.M. Skin and Cosmetology Clinic | |
| Mumbai, Maharashtra, India, 400016 | |
| Dr. Satish Udare Clinic | |
| Mumbai, Maharashtra, India, 400705 | |
| G. T. Hospital Grant Medical College, | |
| Mumbai, Maharashtra, India, 400001 | |
| Dr. Lokesh Siddana Jappa Clinic | |
| Nagpur, Maharashtra, India, 440024 | |
| Dr. Vikrant Saoji | |
| Nagpur, Maharashtra, India, 440010 | |
| NKP Salve Institute of Medical Sciences and Lata Maneshkar Hospital | |
| Nagpur, Maharashtra, India, 440019 | |
| Skin Care Clinic | |
| Nagpur, Maharashtra, India, 440009 | |
| Dr. Vijay Manekar | |
| Nashik, Maharashtra, India, 422002 | |
| Deepak Kotkar Clinic | |
| Nashik, Maharashtra, India, 422002 | |
| Milind Deshmukh Clinic | |
| Nashik, Maharashtra, India, 422009 | |
| Skin Clinic | |
| Nashik, Maharashtra, India, 422101 | |
| Skin Care Clinic | |
| Nashik, Maharashtra, India, 422 013 | |
| Alok Clinic | |
| Panvel, Maharashtra, India, 410206 | |
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
| Principal Investigator: | Vijay Aswani, MD | Cutiz Clinic |
| Principal Investigator: | Sandeep Buddhadeo, MD | Skin Care Clinic |
| Principal Investigator: | Milind Deshmukh, MD | Dr. Milind Deshmukh |
| Principal Investigator: | K Y Guruprasad, MD | KBN Institute of Medical Sciences and KBN General & Teaching Hospital, |
| Principal Investigator: | Rizwan Haq, MD | Radiance Skin Clinic |
| Principal Investigator: | Lokesh Siddana Jappa, MD | Dr. Lokesh Siddana Jappa |
| Principal Investigator: | Deepak Kotkar Kotkar, MD | Dr,. Deepak Kotkar Clinic |
| Principal Investigator: | Rahul Kote | Skin Care Clinic, |
| Principal Investigator: | Dipak Kulkarni, MD | Alok Clinic |
| Principal Investigator: | Vijay Manekar, MD | Dr. Vijay Manekar |
| Principal Investigator: | Sudhir Medhekar, MD | G.T. Hospital |
| Principal Investigator: | Nimesh Mehta, MD | N.M. Skin and Cosmetology Clinic |
| Principal Investigator: | Kiran Nabar, MD | Pooja Clinic |
| Principal Investigator: | Sushil Pande, MD | NKP Salve Institute of Medical Sciences and Lata Maneshkar Hospital |
| Principal Investigator: | Sachin Patel, MD | Dr. Sachin Patel Clinic |
| Principal Investigator: | Vikrant Saoji, MD | Dr. Vikrant Saoji |
| Principal Investigator: | Vinod Titarmare, MD | Skin Care Clinic |
| Principal Investigator: | R G Torsekar, MD | Kiran Pratap Clinic |
| Principal Investigator: | Satish Udare, MD | Dr. Satish Udare |
| Principal Investigator: | Suneel Vartak, MD | Skin Clinic |
| Principal Investigator: | Vijay Zawar, MD | Dr. Vijay Zawar |
More Information
No publications provided
| Responsible Party: | Taro Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT01119742 History of Changes |
| Other Study ID Numbers: | BTNF-0909 |
| Study First Received: | May 6, 2010 |
| Last Updated: | January 19, 2012 |
| Health Authority: | India: Ministry of Health United States: Food and Drug Administration |
Keywords provided by Taro Pharmaceuticals USA:
|
Tinea Pedis Interdigital |
Additional relevant MeSH terms:
|
Tinea Tinea Pedis Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases Foot Dermatoses Foot Diseases Pruritus Skin Manifestations Signs and Symptoms |
Clotrimazole Miconazole Butenafine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents |
ClinicalTrials.gov processed this record on May 21, 2013