Trial Outcomes & Findings for Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test) (NCT NCT04531540)

Last Updated: 2020-11-17

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: 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

225 participants

Primary outcome timeframe

After 4 weeks

Results posted on

2020-11-17

Participant Flow

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).

A total of 225 subjects were enrolled in the study and 222 received study treatment.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	225
Overall Study Treated	222
Overall Study COMPLETED	216
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	1
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	4
Overall Study Found to be Ineligible	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Repeated Insult Patch Test n=225 Participants 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.
Age, Continuous	55.2 Years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	154 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	38 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized African American	23 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/American Indian	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Available	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 4 weeks

Outcome measures

Outcome measures
Measure	Repeated Insult Patch Test n=2184 Test site 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.
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects score=0	2182 Test site
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Enrolled Subjects score=0.5	2 Test site

PRIMARY outcome

Timeframe: After 6 weeks

Outcome measures

Outcome measures
Measure	Repeated Insult Patch Test n=1296 Test site 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.
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects score=0	1296 Test site
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Enrolled Subjects score=0.5	0 Test site

PRIMARY outcome

Timeframe: After 4 weeks

Population: Subjects who received treatment and completed the trial and had evaluable data

Outcome measures

Outcome measures
Measure	Repeated Insult Patch Test n=2160 Test site 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.
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects score=0	2158 Test site
Irritation Response Evaluation According to Erythema Scoring Scale During Induction Phase - All Evaluable Subjects score=0.5	2 Test site

PRIMARY outcome

Timeframe: After 6 weeks

Population: Subjects who received treatment and completed the trial and had evaluable data

Outcome measures

Outcome measures
Measure	Repeated Insult Patch Test n=1296 Test site 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.
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects score=0	1296 Test site
Allergic Reaction Evaluation According to Erythema Scoring Scale During Challenge Phase - All Evaluable Subjects score=0.5	0 Test site

Adverse Events

Repeated Insult Patch Test

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Repeated Insult Patch Test n=225 participants at risk 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.
Nervous system disorders Headache	0.44% 1/225 • 6 weeks
Renal and urinary disorders Renal calculi	0.44% 1/225 • 6 weeks
Infections and infestations Enterocolitis infectious	0.44% 1/225 • 6 weeks
Infections and infestations Sinusitis	0.44% 1/225 • 6 weeks
Infections and infestations Urinary Tract Infection	0.44% 1/225 • 6 weeks
Gastrointestinal disorders Toothache	0.44% 1/225 • 6 weeks
Skin and subcutaneous tissue disorders Other - Irritation	0.44% 1/225 • 6 weeks

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