Trial Condition(s):
Photoallergy
To test for photo allergy reaction of sunscreens
Bayer Identifier:
18291
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Pinellas Park, United States, 33781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized study to assess the potential for photoallergy of SPF 50 Y65 110, SPF 50 Y51 002 and SPF 15 V27 104 in human subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Single Blind
Assignment:
Single Group Assignment
Trial Arms:
1
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)Timeframe: up to 3 weeks
- 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 skinTimeframe: up to 3 weeks
Secondary Outcome
- Adverse event collection as a measure of safety and tolerabilityTimeframe: up to 3 weeks
Additional Information
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