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18791 - Sun Protection Factor Assay (SFP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682628
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To evaluate the Sun Protection Factor (SPF) efficacy on human skin.

Condition or disease Intervention/treatment Phase
Sunscreening Agent Drug: Coppertone (BAY987517) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)
Actual Study Start Date : February 18, 2016
Actual Primary Completion Date : February 22, 2016
Actual Study Completion Date : February 22, 2016

Arm Intervention/treatment
Experimental: BAY987517
Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Drug: Coppertone (BAY987517)
Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.




Primary Outcome Measures :
  1. Minimal Erythema Dose (MED) [ Time Frame: Up to 15 minutes ]
  2. Minimal Persistent Pigment DArkening Dose (MPPD) [ Time Frame: Up to 15 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
  • Male and female
  • Aged between 18-70 years old.
  • Good health as determined from the HRL SHF
  • Signed and dated Informed Consent Form
  • Signed and dated HIPAA Form
  • An unbmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

  • Subjects on test at any other research laboratory or clinic.
  • Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
  • Pre-existing dermatologic conditions which have been dianoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
  • Pre-existing other medical conditions (e.g. adult asthma. diabetes).
  • Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
  • Treatment with antibiotics within two weeks prior to initiation of the test.
  • Chronic medication which could affect the results of the study.
  • Known pregnant or nursing women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682628


Locations
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United States, New Jersey
Union, New Jersey, United States, 07083
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02682628    
Other Study ID Numbers: 18791
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No