Phase 3
Completed N=10
Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)
Sun Protection
Source: ClinicalTrials.gov NCT01001975 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: Determination of Sunscreen Protection Factor (SPF) — 14.72; 15.00 Score on a scale
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 ensulizole.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determination of Sunscreen Protection Factor (SPF) |
14.72; 15.00 | — |
| PRIMARY Determination of Ultraviolet A Protection Factor (PFA) |
11.60; 10.50 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01001975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.