Sunscreen Agents
Conditions
Brief summary
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
Interventions
DRUGBAY987516
2.00 mg/cm2 ± 0.04 mg/cm2
DRUGSPF 15 Control
2.00 mg/cm2 ± 0.04 mg/cm2
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion | up to 24 hours post-exposure | 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. |
| Sun Protection Factor (SPF) efficacy on the skin of human subjects after a total of 2 hours of water Immersion | up to 24 hours post-exposure | 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. |
Countries
United States
Outcome results
None listed