check_circleStudy Completed
Photoallergy
Bayer Identifier:
18291
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
To test for photo allergy reaction of sunscreens
Trial purpose
The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.
The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
56Trial Dates
March 2015 - May 2015Phase
N/ACould I Receive a placebo
NoProducts
BAY987519Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pinellas Park, 33781, United States |
Primary Outcome
- Evaluation of inflammatory responsesInflammatory responses (Based on scores): 0 = No visible reaction + = Slight, confluent, or patchy erythema 1 = Mild erythema (pink) 2 = Moderate erythema (definite redness) 3 = Strong erythema (very intense redness)date_rangeTime Frame:up to 3 weeksenhanced_encryptionYesSafety Issue:
- Evaluation of superficial effectsSuperficial effects: g = Glazing y = Peeling c = Scab, dried film of serous exudate of vesicular or bulla reaction d = Hyperpigmentation (reddish brown discoloration of test site) h = Hypopigmentation (loss of visible pigmentation at test site) f = Fissuring grooves in the superficial layers of the skindate_rangeTime Frame:up to 3 weeksenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Adverse event collection as a measure of safety and tolerabilitydate_rangeTime Frame:up to 3 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
Single BlindAssignment
Single Group AssignmentTrial Arms
1