Trial Outcomes & Findings for Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test) (NCT NCT04531813)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

32 participants

Primary outcome timeframe

21 days

Results posted on

2020-09-25

Participant Flow

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).

A total of 32 participants were enrolled in the study and 31 received study treatment.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	32
Overall Study Treated	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cumulative Irritation Test n=32 Participants 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.
Age, Continuous	51.1 Years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	20 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized African-American	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Subjects who received treatment and completed the study

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.

Outcome measures

Outcome measures
Measure	Cumulative Irritation Test n=30 Participants 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.
Cumulative Irritation Total (CIT) Score Butenafine HCl 1%	0.0 Score on a scale
Cumulative Irritation Total (CIT) Score 0.3% SLS	20.0 Score on a scale
Cumulative Irritation Total (CIT) Score Negative Control	0.0 Score on a scale

Adverse Events

Cumulative Irritation Test

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cumulative Irritation Test n=32 participants at risk 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.
Nervous system disorders Headache	3.1% 1/32 • 21 days

Additional Information

Therapeutic Area Head

BAYER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No information based on the conduct of the study (incl. protocol, data resulting from the study, or the fact that the study was being conducted) will be released without prior written consent of the sponsor unless the requirement is superseded by State or Federal law.
Publication restrictions are in place

Restriction type: OTHER