check_circleStudy Completed
Dermatitis, Phototoxic
Bayer Identifier:
18154
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
In this study researchers want to gather information about the potential of Antifungal Cream V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic reaction is an irritant reaction of the skin to ultra violet light. In order to find this out the study drug will be applied to the skin of healthy human subjects. By using a solar simulator to generate a UV spectrum similar to that of sunlight the potential of the study drug to produce a superficial reddening of the skin will be measured.
Key Participants Requirements
Sex
AllAge
18 - 60 YearsTrial summary
Enrollment Goal
32Trial Dates
June 2013 - June 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
- Phototoxic reaction evaluation reported as number of test site with different erythema scoreEvaluation 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.date_rangeTime Frame:4 days
Secondary Outcome
- Development of erythema on the treated non-irradiated test sites, which would indicate irritant contact dermatitis and a pre-existing allergic contact dermatitisEvaluation 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.date_rangeTime Frame:4 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1