Sun Protection Factor (SPF) Efficacy Assay

NCT02885805 | Completed

• 1 other identifier: 18322
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sunscreen Agents

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SPF evaluation + Control

EXPERIMENTAL

Fair-skinned subjects in good health with Skin Types I, II or III.

Drug: BAY987516; Drug: SPF 15 Control

Interventions

BAY987516 DRUG

2.00 mg/cm2 ± 0.04 mg/cm2

SPF evaluation + Control

SPF 15 Control DRUG

2.00 mg/cm2 ± 0.04 mg/cm2

SPF evaluation + Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Union, New Jersey, 07083, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: September 1, 2016
• Study Start: June 26, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)