Sun Protection Factor (SPF) Efficacy Assay

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Drug: BAY987516; Drug: SPF 15 Control

• Registration Number: NCT02885805
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-26
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-09-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPF evaluation + Control	BAY987516	Fair-skinned subjects in good health with Skin Types I, II or III.
SPF evaluation + Control	SPF 15 Control	Fair-skinned subjects in good health with Skin Types I, II or III.

Primary Outcome Measures

Name	Time	Method
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.