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Clinical Trials/NCT02872233
NCT02872233CompletedNot Applicable

Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay

Bayer0 sites6 target enrollmentStarted: May 26, 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Bayer
Enrollment
6
Primary Endpoint
Evaluation of 2 hours water resistant SPF
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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).

Exclusion Criteria

  • Not provided

Arms & Interventions

SPF evaluation

Experimental

Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.

Intervention: BAY 987519 (Drug)

SPF evaluation

Experimental

Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.

Intervention: SPF 15 Control (Drug)

Outcomes

Primary Outcomes

Evaluation of 2 hours water resistant SPF

Time Frame: 16-24 h post exposure

ISO/COLIPA Sun Protection FactorTest Method.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

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Sun Protection Factor (SPF) / UVA... | Clinical Trial