check_circleStudy Completed
Dermatitis, Photoallergic
Bayer Identifier:
18155
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to find out if cream V61-044 used to treat fungal infections causes an allergic skin reaction to sunlight in healthy participants
Trial purpose
Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted to find out if cream V61-044 might cause an allergic skin reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small growing organisms such as mold, mildew, yeast or mushrooms).
Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.
Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.
Key Participants Requirements
Sex
AllAge
18 - 60 YearsTrial summary
Enrollment Goal
137Trial Dates
June 2013 - November 2013Phase
Phase 3Could I Receive a placebo
NoProducts
LOTRIMIN ULTRA (Butenafine HCl, BAY1896425)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Fairfield, 07004, United States |
Primary Outcome
- Photoallergic reaction evaluation reported as number of test site with different erythema score during Challenge Phase - All treated subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.date_rangeTime Frame:At 24, 48, and 72 hours following patch application
- Photoallergic reaction evaluation reported as number of test site with different erythema score during Challenge Phase - All evaluable subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.date_rangeTime Frame:At 24, 48, and 72 hours following patch application
Secondary Outcome
- Development of erythema on treated irradiated test sites during Induction Phase - All treated subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The number of test sites with available scores from all 6 induction patches were reported for all treated subjects.date_rangeTime Frame:Two or three days after each irradiation during Induction Phase
- Development of erythema on the treated non-irradiated test sites during Induction Phase - All treated subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The mean score of test sites with available scores from all 6 induction patches were reported for all treated subjects.date_rangeTime Frame:Two or three days after each irradiation during Induction Phase
- Development of erythema on the treated non-irradiated test sites during Challenge Phase reported as number of test site with different erythema score - All treated subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all treated subjects.date_rangeTime Frame:At 24, 48, and 72 hours following patch application
- Development of erythema on treated irradiated test sites during Induction Phase - All evaluable subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The number of test sites with available scores from all 6 induction patches were reported for all evaluable subjects.date_rangeTime Frame:Two or three days after each irradiation during Induction Phase
- Development of erythema on the treated non-irradiated test sites during Induction Phase - All evaluable subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Induction Phase, each subject had the following two test sites: Treated irradiated test site and Treated non-irradiated test site. The mean score of test sites with available scores from all 6 induction patches were reported for all evaluable subjects.date_rangeTime Frame:Two or three days after each irradiation during Induction Phase
- Development of erythema on the treated non-irradiated test sites during Challenge Phase reported as number of test site with different erythema score - All evaluable subjectsEvaluation of the test sites after irradiation used following scoring system: score 0=normal skin (no visible reaction); 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 with well defined edema; score 4=redness with papules, vesicles, or ulceration. During Challenge Phase, each subject had the following four virgin test sites: Treated irradiated test site; Treated non-irradiated test site; Untreated irradiated test site; Untreated non-irradiated test site. All four test sites were evaluated according to the above scoring system at 24, 48, and 72 hours following patch application (3 different time points), and the number of test sites with available scores from all these time points were reported for all evaluable subjects.date_rangeTime Frame:At 24, 48, and 72 hours following patch application
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1