Hypersensitivity
Conditions
Brief summary
In this study researchers want to study the potential skin reaction after repeated application of an antifungal cream containing trolamine. The study plans to enroll about 32 healthy female or male participants with the age 18 - 79 years. Researchers will apply on the skin of the upper back between the shoulder blades of the study participants three different patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl sulfate, which is known to cause skin irritation (so called positive control). A third patch will cover a skin area without any product (so called negative control). Participants will return daily to the study center to have new patches containing the test products applied on the same skin area of the back, excluding weekends, for 21 days of continuous skin contact. At each visit the skin will be investigated by the researchers for redness, dryness and other reactions to learn about the skin reaction after repeated application.
Interventions
Approximately 0.2 g of cream containing butenafine HCl 1% daily (excluding weekends) was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the skin test site. The total dose applied to each participant completing the trial was 3 g.
DRUGPositive Control-Sodium lauryl sulfate (SLS)
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.
OTHERNegative Control
A blank patch was applied to the Negative Control test site.
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
* Participants must have been aged 18 to 79 years, inclusive. * Participants must have understood and executed an Informed Consent Form (ICF). * Participants (if female) must have been willing to take a urine pregnancy test prior to the initiation and at the completion of the trial. * Participants must have been capable of understanding and following directions. * Participants must have been considered reliable.
Exclusion criteria
* Participants who were in ill health or taking medication, other than birth control, which could have influenced the purpose, integrity or outcome of the trial. * Participants who had any visible skin disease that might have been confused with a skin reaction to the test material. * Participants who were participating in another clinical trial at this facility or any other facility. * Participants who were using topical or systemic steroids or antihistamines for at least 7 days prior to trial initiation and during the duration of the trial. * Participants who had a history of adverse reaction to adhesive tape, cosmetics, over-the-counter (OTC) drugs or other personal care products. * Participants judged by the principal investigator (PI) to be inappropriate for the trial. * Female participants who were pregnant as evidenced by a positive urine pregnancy test, planning to become pregnant, or nursing during the course of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Irritation Total (CIT) Score | 21 days | 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. |
Countries
United States
Participant flow
Recruitment details
Study was conducted at single center in the US, between 10 JUN 2013 (first subject first visit) and 1 JUL 2013 (last subject last visit).
Pre-assignment details
A total of 32 participants were enrolled in the study and 31 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cumulative Irritation Test 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cumulative Irritation Test |
|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 12.5 |
| Race/Ethnicity, Customized African-American | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Cumulative Irritation Total (CIT) Score
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.
Time frame: 21 days
Population: Subjects who received treatment and completed the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cumulative Irritation Test | Cumulative Irritation Total (CIT) Score | Butenafine HCl 1% | 0.0 Score on a scale |
| Cumulative Irritation Test | Cumulative Irritation Total (CIT) Score | 0.3% SLS | 20.0 Score on a scale |
| Cumulative Irritation Test | Cumulative Irritation Total (CIT) Score | Negative Control | 0.0 Score on a scale |