Sun Protection Factor (SPF) Efficacy Assay

Sunscreen Agents Clinical Trial

Official title:

Sun Protection Factor (SPF) Efficacy Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885805
• Other study ID #: 18322
• Status: Completed
• Phase: N/A
• Start date: June 26, 2015
• Est. completion date: July 1, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sunscreen Agents

Intervention

Drug:
• BAY987516
2.00 mg/cm2 ± 0.04 mg/cm2
• SPF 15 Control
2.00 mg/cm2 ± 0.04 mg/cm2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

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