Hypersensitivity
Conditions
Brief summary
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.
Interventions
Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects | After 4 weeks | 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. |
| Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects | After 6 weeks | 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. |
| Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects | After 4 weeks | 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. |
| Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects | After 6 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
A total of 225 subjects were enrolled in the study and 222 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Repeated Insult Patch Test 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. | 225 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Found to be Ineligible | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Repeated Insult Patch Test |
|---|---|
| Age, Continuous | 55.2 Years STANDARD_DEVIATION 14.3 |
| Race/Ethnicity, Customized African American | 23 Participants |
| Race/Ethnicity, Customized American Indian | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 154 Participants |
| Race/Ethnicity, Customized Caucasian/African American | 1 Participants |
| Race/Ethnicity, Customized Caucasian/American Indian | 1 Participants |
| Race/Ethnicity, Customized Caucasian/Hispanic | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 38 Participants |
| Race/Ethnicity, Customized Not Available | 1 Participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 225 |
| serious Total, serious adverse events | 0 / 225 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Repeated Insult Patch Test | Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects | score=0 | 1296 Test site |
| Repeated Insult Patch Test | Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects | score=0.5 | 0 Test site |
Primary
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
Population: Subjects who received treatment and completed the trial and had evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Repeated Insult Patch Test | Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects | score=0 | 1296 Test site |
| Repeated Insult Patch Test | Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects | score=0.5 | 0 Test site |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Repeated Insult Patch Test | Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects | score=0 | 2182 Test site |
| Repeated Insult Patch Test | Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects | score=0.5 | 2 Test site |
Primary
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
Population: Subjects who received treatment and completed the trial and had evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Repeated Insult Patch Test | Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects | score=0 | 2158 Test site |
| Repeated Insult Patch Test | Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects | score=0.5 | 2 Test site |