Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test)

Study Overview
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Brief Summary
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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.

Official Title
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HT201321- Repeated Insult Patch Test With Modified Challenge

Conditions
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Hypersensitivity

Intervention / Treatment
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* Drug: Butenafine HCl 1% (BAY1896425)


Participation Criteria
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Eligibility Criteria
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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 Criteria: Subjects who were in ill health or taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial; Subjects who had any visible skin disease that might be confused with a skin reaction to the test material; Subjects who were participating in another clinical trial at this facility or any other facility; Subjects who used topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial; Subjects who had a history of adverse reactions to adhesive tape, cosmetics, OTC drugs or other personal care products; Subjects judged by the PI to be inappropriate for the trial; Female subjects who were pregnant as evidenced by a urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated Insult Patch Test<br>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)<br>* Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.<br>* Other names: Antifungal Cream V61-044 containing Trolamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | After 6 weeks |