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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00781820 |
The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.
Condition | Intervention | Phase |
---|---|---|
Onychomycosis |
Drug: Bifonazole cream 1% Drug: Placebo cream |
Phase III |
Study Type: | Interventional |
Study Design: | Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment |
Official Title: | A Double-Blind, Randomized, Multicenter, Placebo- Controlled Phase 3 Trial to Prove the Superiority of Bifonazole vs. Placebo After 4 Weeks of Onychomycosis Treatment/ as a Follow-up of a 2 Weeks Treatment of Non-Surgical Nail Ablation of Diseased Nail Matrix With 40% Urea Paste |
Estimated Enrollment: | 700 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 2: Placebo Comparator |
Drug: Placebo cream
1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
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Arm 1: Experimental |
Drug: Bifonazole cream 1%
1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Consumer Care AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12999, EudraCT: 2008-003215-13 |
Study First Received: | October 28, 2008 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00781820 History of Changes |
Health Authority: | Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Poland: Ministry of Health |
Bifonazole Nail fungus Placebo Urea |
Mycoses Bifonazole Skin Diseases, Infectious Onychomycosis Skin Diseases Clotrimazole |
Miconazole Antifungal Agents Tioconazole Tinea Dermatomycoses |
Anti-Infective Agents Bifonazole Skin Diseases Infection Pharmacologic Actions Mycoses Skin Diseases, Infectious |
Onychomycosis Nail Diseases Antifungal Agents Therapeutic Uses Tinea Dermatomycoses |