Trial Outcomes & Findings for Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects (NCT NCT04531527)

Results Overview

Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

32 participants

Primary outcome timeframe

Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation

Results posted on

2020-11-13

Participant Flow

Study was conducted at single center in the US, between 24 JUN 2013 (first subject first visit) and 28 JUN 2013 (last subject last visit).

A total of 32 subjects were enrolled in the study and 29 received study treatment.

Participant milestones

Participant milestones
Measure	Phototoxicity Reaction Test Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
Overall Study STARTED	32
Overall Study Treated	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Phototoxicity Reaction Test Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
Overall Study Found to be Ineligible	3

Baseline Characteristics

Study to Learn More About the Potential of Antifungal Cream V61-044 Containing Trolamine to Cause Irritant Reaction of the Skin to Ultra Violet Light in Healthy Human Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phototoxicity Reaction Test n=32 Participants Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
Age, Continuous	40.8 Years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/Hispanic	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation

Population: Subjects who received treatment

Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites).

Outcome measures

Outcome measures
Measure	Phototoxicity Reaction Test n=87 Test site Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Treated irradiated test site, score=0	77 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Treated irradiated test site, score=1	10 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Treated non-irradiated test site, score=0	85 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Treated non-irradiated test site, score=1	2 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Untreated irradiated test site, score=0	78 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Untreated irradiated test site, score=1	9 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Untreated non-irradiated test site, score=0	85 Test site
Phototoxic Reaction Evaluation Reported as Number of Test Site With Different Erythema Score Untreated non-irradiated test site, score=1	2 Test site

SECONDARY outcome

Timeframe: Immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation

Population: Subjects who received treatment

Evaluation of the test sites after irradiation used following scoring system: score 0=Normal skin; score 1=Faint, barely perceptible to moderate redness with poorly defined margins (not clinically significant); score 2=Moderate to intense redness with well defined margins; score 3=Redness plus well defined edema; score 4=Redness plus papules, vesicles, or ulceration. All four test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system immediately before irradiation, 24 hours after irradiation, and 48 hours after irradiation (3 different time points), thus for each type of test site (i.e. treated irradiated test site), a total of 87 test sites with scores were collected (i.e., 29 participants \*3 time points = 87 sites).

Outcome measures

Outcome measures
Measure	Phototoxicity Reaction Test n=87 Test site Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by UV irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis Treated non-irradiated test site, score=0	85 Test site
Development of Erythema on the Treated Non-irradiated Test Sites, Which Would Indicate Irritant Contact Dermatitis and a Pre-existing Allergic Contact Dermatitis Treated non-irradiated test site, score=1	2 Test site

Adverse Events

Phototoxicity Reaction Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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