Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Butenafine 1% · 3 trials · 2 indications
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: score 0=No visible erythema; score 0.5=Slight, barely perceptible erythema; score 1=Mild erythema; score 2=Moderate erythema; score 3=Marked erythema; score 4=Severe erythema.
Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites).
Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythema Scoring Scale: 0 = No visible erythema; 0.5 = Slight, barely perceptible erythema; 1 = Mild erythema; 2 = Moderate erythema; 3 = Marked erythema; 4 = Severe erythema. The Cumulative Irritation Total is generated by totaling the Erythema Scoring Scale scores of the Investigational Product for each subject completing the trial and then adding those totals. Data is being reported for all the 30 participants as a group.
| Arm | Type | Description |
|---|---|---|
| Repeated Insult Patch Test | EXPERIMENTAL | During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system. |
| Phototoxicity reaction test | EXPERIMENTAL | Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by Ultraviolet Radiation (UV) irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation. |
| Cumulative Irritation Test | EXPERIMENTAL | Participants received butenafine HCl 1% cream on the skin test site, 0.3% solution of sodium lauryl sulfate on the skin Positive Control test site, and a blank patch on the skin Negative Control test site daily (excluding weekends) for 21 days, or 15 applications. |
| Name | Type | Description |
|---|---|---|
| Butenafine HCl 1% (BAY1896425) | DRUG | Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin. |
| Positive Control-Sodium lauryl sulfate (SLS) | DRUG | Approximately 0.2 mL of 0.3% solution of sodium lauryl sulfate was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the Positive Control test site. |
| Negative Control | OTHER | A blank patch was applied to the Negative Control test site. |
Inclusion Criteria: * Subjects must have been aged 18 to 79 years, inclusive; * Female subjects must have produced a negative urine pregnancy test prior to the initiation and also at the completion of the trial; * Subjects must have been capable of understanding and following directions. Exclusion...
Butenafine 1% is an investigational small molecule antifungal cream being studied for use in dermatology conditions including hypersensitivity, dermatitis, photoallergic dermatitis, and phototoxic dermatitis. It is currently in Phase 3 clinical development by Bayer AG.
Butenafine 1% is an antifungal agent, but its specific molecular target has not been disclosed in the available information. It is being studied for its potential to treat fungal infections and related skin reactions.
Butenafine 1% is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY.
Butenafine 1% is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. All four clinical trials associated with it have been completed.
Butenafine 1% has been studied in four completed Phase 3 clinical trials: NCT04531527, NCT04531540, NCT04531813, and NCT04532164. These trials evaluated skin irritation, sensitization, and photoallergic reactions in healthy volunteers in the United States.
Butenafine 1% is also known as V61-044, as referenced in the clinical trial titles. The trials describe it as an antifungal cream containing trolamine, and it is being studied for its potential to cause irritant or allergic skin reactions.