Sun Protection Factor Assay (SPF Assay 105/2016)
|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: NCT02891044|
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : December 13, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Sunscreening Agents||Drug: BAY987517||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose|
|Actual Study Start Date :||August 15, 2016|
|Actual Primary Completion Date :||September 8, 2016|
|Actual Study Completion Date :||September 8, 2016|
Each test site area is divided into test sub site 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.
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 Code: Z44-040)
- Minimal Erythema Dose (MED) [ Time Frame: Up to 15 minutes ]
- 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|
- 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 (Subject History Form).
- Signed and dated Informed Consent Form.
- Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
- An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)
- 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.
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): NCT02891044
|United States, New Jersey|
|Union, New Jersey, United States, 07083|
|Other Study ID Numbers:||
|First Posted:||September 7, 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|