Sun Protection Factor (SPF) Efficacy Assay

Study Overview
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Brief Summary
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Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Official Title
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Sun Protection Factor (SPF) Efficacy Assay

Conditions
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Sunscreen Agents

Intervention / Treatment
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* Drug: BAY987516
* Drug: SPF 15 Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation + Control<br>Fair-skinned subjects in good health with Skin Types I, II or III. | Drug: BAY987516<br>* 2.00 mg/cm2 ± 0.04 mg/cm2<br>Drug: SPF 15 Control<br>* 2.00 mg/cm2 ± 0.04 mg/cm2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion | The 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. | 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 Immersion | The 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. | up to 24 hours post-exposure |