Trial Condition(s):
Sunscreen agents
Sun Protection Factor (SPF) efficacy Assay
Bayer Identifier:
18322
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
Inclusion Criteria
: - Fitzpatrick Skin Type I, II and/or 111 for UVB testing; Fitzpatrick Skin Type II, 111 and/or IV for UVA testing. - Sex: Male or female. - Age: 18-70 years. - Good health as determined from the HRL SHF. - Signed and dated lnformed Consent Form. - Signed and dated HIPAA Form. - An unambiguous MED or MPPD
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
11
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
BAY987516
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Union, United States, 07083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Sun Protection Factor (SPF) efficacy Assay
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water ImmersionThe subsites on each of the protected test sites [test sunscreen and/or Control] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle [3"'] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.Timeframe: up to 24 hours post-exposure
- Sun Protection Factor (SPF) efficacy on the skin of human subjects after a total of 2 hours of water ImmersionThe subsites on each of the protected test sites [test sunscreen and/or Control] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle [3"'] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.Timeframe: up to 24 hours post-exposure
Additional Information
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