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18751-Sun Protection Factor Assay. (SPF Assay)

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ClinicalTrials.gov Identifier: NCT02739802
Recruitment Status : Completed
First Posted : April 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 Agents Drug: Coppertone(BAY987517) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 30, 2016

Arm Intervention/treatment
Experimental: BAY 987517
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.Formulation number - SR16-02.




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 ]


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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 or female - Aged between 18-70 years old. - Good health - Signed and dated Informed Consent Form - Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form - An unambiguous MED 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 diagnoses 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): NCT02739802


Locations
United States, New Jersey
Union, New Jersey, United States, 07083
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02739802     History of Changes
Other Study ID Numbers: 18751
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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