A Phase 3 interventional study of Butenafine HCl 1% (BAY1896425) in Hypersensitivity, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 225 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
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.
Drug: Butenafine HCl 1% (BAY1896425)
Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
Also known as: Antifungal Cream V61-044 containing Trolamine
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects
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.
Time frame: After 4 weeks
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects
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.
Time frame: After 6 weeks
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects
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.
Time frame: After 4 weeks
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects
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.
Time frame: After 6 weeks
Study was conducted at single center in the US, between 9 SEP 2013 (first subject first visit) and 18 OCT 2013 (last subject last visit).
| Milestone | Repeated Insult Patch Test |
|---|---|
| Started | 225 |
| Treated | 222 |
| Completed | 216 |
| Not completed | 9 |
| Withdrew: Adverse event | 1 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Found to be ineligible | 1 |
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.
| Test site | Repeated Insult Patch Test |
|---|---|
| score=0 | 2182 |
| score=0.5 | 2 |
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.
| Test site | Repeated Insult Patch Test |
|---|---|
| score=0 | 1296 |
| score=0.5 | 0 |
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.
| Test site | Repeated Insult Patch Test |
|---|---|
| score=0 | 2158 |
| score=0.5 | 2 |
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.
| Test site | Repeated Insult Patch Test |
|---|---|
| score=0 | 1296 |
| score=0.5 | 0 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Repeated Insult Patch Test | — | 0/225 (0%) | 6/225 (2.7%) |
| Event | Repeated Insult Patch Test |
|---|---|
| HeadacheNervous system disorders | 1/225 |
| Renal calculiRenal and urinary disorders | 1/225 |
| Enterocolitis infectiousInfections and infestations | 1/225 |
| SinusitisInfections and infestations | 1/225 |
| Urinary Tract InfectionInfections and infestations | 1/225 |
| ToothacheGastrointestinal disorders | 1/225 |
| Other - IrritationSkin and subcutaneous tissue disorders | 1/225 |
| Age, Continuous(Years) | Repeated Insult Patch Test |
|---|---|
| Mean | 55.2 ± 14.3 |
| Sex: Female, Male(Participants) | Repeated Insult Patch Test |
|---|---|
| Female | 159 |
| Male | 66 |
| Race/Ethnicity, Customized(Participants) | Repeated Insult Patch Test |
|---|---|
| Caucasian | 154 |
| Hispanic | 38 |
| Caucasian/Hispanic | 3 |
| African American | 23 |
| Caucasian/African American | 1 |
| Caucasian/American Indian | 1 |
| American Indian | 1 |
| Asian | 3 |
| Not Available | 1 |
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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