Status:
COMPLETED
Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)
Lead Sponsor:
Bayer
Conditions:
Sun Protection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensu...
Eligibility Criteria
Inclusion
- 18 to 70 years of age
- Have Fitzpatrick skin types I, II, or III
- In good general health based on a medical history review
- Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation
- Be able to cooperate with the investigator and research staff
- Be willing to have the test materials applied according to the protocol
- Be capable of understanding and provide written informed consent
Exclusion
- Subjects with a history of adverse effects upon sun exposure
- Subjects currently taking any medication that may alter the sunlight response or is a known photosensitizer
- Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria cutanea tarda, connective tissue disease, diabetes or any disease that would increase the risks associated with study participation
- Subjects with an abnormal sensitivity to any sunscreen agent
- Females who indicate that they are pregnant or nursing an infant during the period of the study
- Subjects with excessive hair, blemishes, nevi, warts, moles, scars, sunburn, suntan or uneven pigmentation in the test areas
- Subjects who have been administered an investigations drug or have participated in another SPF or PFA study within 30 days prior to this study
- Subjects who are allergic to latex or latex products
- Subjects who have any conditions that would make study participation inappropriate as determined by the investigator
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01001975
Start Date
July 1 2009
End Date
August 1 2009
Last Update
March 11 2015
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