To Test for Photo Allergy Reaction of Sunscreens
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Men or women, aged 18 to 65 with good general health
- Fitzpatrick skin type I IV
- Females (of childbearing potential) on acceptable measure of contraception
- Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
- Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
56 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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