Sun Protection Factor (SPF) Assay
1 other identifier
interventional
12
1 country
1
Brief Summary
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2015
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedDecember 12, 2018
December 1, 2018
22 days
July 29, 2016
December 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of water resistant SPF in accordance to 21 CFR (Code of Federal Regulations) 207.327
16-24 h post exposure
Study Arms (1)
SPF evaluation
EXPERIMENTALSubjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were considered for SPF testing.
Interventions
Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Eligibility Criteria
You may qualify if:
- Male or female of an age of 18 to 70 years inclusive;
- Fitzpatrick Skin Type I, II and/or III for SPF testing;
- Good health as determined from the CRO Subject History Form (SHF);
- Signed and dated Informed Consent Form;
- Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
- An unambiguous minimal erythema dose (MED).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Union, New Jersey, 07083, United States
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
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
July 29, 2016
First Posted
August 5, 2016
Study Start
May 18, 2015
Primary Completion
June 9, 2015
Study Completion
June 9, 2015
Last Updated
December 12, 2018
Record last verified: 2018-12