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Also known as Butenafine HCl 1% (BAY1896425), Butenafine HCl 1% (BAY1896425) - Induction Phase, Butenafine 1%- Induction Phase
Butenafine 1% · 4 trials · 3 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.
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.
Evaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.
| 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. |
| Photoallergic reaction test | EXPERIMENTAL | During the Induction Phase, participants received Butenafine HCl 1% on the treated irradiated skin test site followed by UV irradiation and on the treated non-irradiated skin test site without UV radiation, two times per week for three consecutive weeks. After 10 days of Rest Phase, during the Challenge Phase, participants received same procedure on the two virgin sites (treated sites) as in Induction Phase, and two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Test sites were evaluated at 24, 48, and 72 hours after irradiation using the same grading scale used during Induction Phase. |
| 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. |
| Butenafine HCl 1% (BAY1896425) - Induction Phase | DRUG | To each of two test sites, approximately 20 μl/cm\^2 of the Butenafine HCl 1% was applied directly to the skin and covered with a 25 mm Hilltop chamber with a Webril pad (2 cm in diameter, within an area of approximately 3 cm\^2), and tape was applied over the chamber to secure the occlusive patch to the skin. On the next day, the chambers were removed and both test sites were lightly wiped. Approximately 2 μl/cm\^2 of Butenafine HCl 1% was reapplied directly to the skin and lightly spread over the treated irradiated test site. The treated non-irradiated test site did not receive a similar reapplication. Between 5 and 15 minutes after application, the treated irradiated test site was irradiated with two times the subject's Minimal Erythema Dose (MED). Evaluation of the test sites occurred two days after the irradiation. This procedure was repeated two times per week for three consecutive weeks for a total of 6 induction exposures per test site. |
| Butenafine HCl 1% (BAY1896425) - Challenge Phase | DRUG | 5 μl/cm\^2 of the Butenafine HCl 1% was applied directly to each of the two virgin sites (treated sites) adjacent to the induction patch sites and covered with Hilltop chambers with Webril pad and tape was applied over the chambers to secure the occlusive patches to the skin. Two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Sites were at least 2.5 cm apart. The patches were removed 24 hours later and the sites were lightly wiped. Test sites were evaluated. Butenafine HCl 1% (2 μl/cm\^2) was applied to the treated irradiated site. After 15 minutes, the treated irradiated site and the untreated irradiated site were irradiated with 0.5 MED of UVA/UVB irradiation followed by 10 Joules/cm\^2 of UVA from a xenon arc solar simulator equipped with a Schott WG345 to eliminate UVB radiation. The remaining sites served as the treated non-irradiated site and untreated non-irradiated 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 a small molecule antifungal cream developed by Bayer AG. It is being studied in Phase 3 trials for skin conditions including photoallergic dermatitis, phototoxic dermatitis, and hypersensitivity. The trials have evaluated its potential to cause allergic skin reactions to sunlight and skin irritation in healthy participants.
Butenafine 1% is being studied for dermatological conditions including photoallergic dermatitis, phototoxic dermatitis, and hypersensitivity. The Phase 3 trials assessed whether the antifungal cream causes allergic skin reactions to sunlight or skin irritation. All completed trials enrolled healthy adult volunteers rather than patients with active fungal infections.
Butenafine 1% is developed by Bayer AG, which trades under the ticker BAYRY. Bayer conducted the Phase 3 studies evaluating the antifungal cream's skin safety profile, including phototoxicity, photoallergy, and irritation potential, in healthy participants in the United States.
Butenafine 1% is in Phase 3 development. All four listed trials are completed, with no active trials ongoing. The studies enrolled a total of 257 participants across the United States and evaluated skin irritation, sensitization, and photosensitivity reactions in healthy volunteers.
Butenafine 1% has been evaluated in completed Phase 3 trials including NCT04532164, which studied photoallergic dermatitis in 137 participants, NCT04531813, which assessed cumulative irritation in 32 participants, NCT04531540, which examined irritation and sensitization in 225 participants, and NCT04531527, which studied phototoxic dermatitis in 32 participants.
Yes, Butenafine 1% is also known as Butenafine HCl 1% (BAY1896425). Additional names used in study records include Butenafine HCl 1% (BAY1896425) - Induction Phase and Butenafine 1% - Induction Phase. These refer to the same Bayer antifungal cream asset.