6 completed, 1 terminated, 1 unknown. 4 Phase 3, 3 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 2 | 1 | Unknown 1 |
Follow butenafine: new trials by email Literature Review of butenafine trials Research Report on butenafine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS TERBINAFINE HYDROCHLORIDE (1%), BUTENAFINE HYDROCHLORIDE (1%), Vehicle Control - Tinea Pedis | Phase 2 | Unknown | United Laboratories | 42 | 2019-01-02 | 2019-06-26 |
| Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test) Butenafine HCl 1% (BAY1896425) - Hypersensitivity | Phase 3 | Completed | Bayer | 225 | 2013-09-09 | 2020-11-17 |
| Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects Butenafine HCl 1% (BAY1896425) - Dermatitis, Phototoxic | Phase 3 | Completed | Bayer | 32 | 2013-06-24 | 2020-11-13 |
| Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants Butenafine HCl 1% (BAY1896425) - Induction Phase, Butenafine HCl 1% (BAY1896425) - Challenge Phase - Dermatitis, Photoallergic | Phase 3 | Completed | Bayer | 137 | 2013-06-10 | 2020-11-16 |
| Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test) Butenafine HCl 1% (BAY1896425), Positive Control-Sodium lauryl sulfate (SLS), Negative Control - Hypersensitivity | Phase 3 | Completed | Bayer | 32 | 2013-06-10 | 2020-09-25 |
| Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis Butenafine Hydrochloride Cream, 1%, Lotrimin Ultra®, Butenafine Vehicle - Tinea Pedis | Phase 1 | Completed | Sun Pharmaceutical Industries, Inc. | 707 | 2012-01-01 | 2017-05-05 |
| Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis Butenafine Hydrochloride 1%, Butenafine Hydrochloride 1% B, Vehicle A - Interdigital Tinea Pedis | Phase 1 | Terminated | Sun Pharmaceutical Industries, Inc. | 428 | 2010-07-01 | 2014-05-06 |
| Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis Butenafine cream 1% manufactured by Taro, Lotrimin Ultra (butenafine) 1%, Butenafine Vehicle manufactured by Taro - Tinea Pedis | Phase 1 | Completed | Sun Pharmaceutical Industries, Inc. | 548 | 2008-06-01 | 2014-02-04 |
Tinea Pedis (4) · Hypersensitivity (2) · Dermatitis, Photoallergic (1) · Dermatitis, Phototoxic (1)
Bayer (4) · Sun Pharmaceutical Industries, Inc. (3) · United Laboratories (1)
United States (5) · Belize (1) · Philippines (1)