Sun Protection Factor Assay (SPF Assay 205/2016)

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02936557

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the Sun Protection Factor efficacy on human skin.

Condition or Disease	Intervention/Treatment	Phase
Sunscreening Agents	Drug: BAY987521	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Actual Study Start Date :

Oct 26, 2016

Actual Primary Completion Date :

Nov 17, 2016

Actual Study Completion Date :

Nov 17, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAY987521 Each test site area is divided into test sub site areas that are approximately at least 0.5 cm2. The application of test material is 2 mg/cm2. Thus, each 50 cm2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm2 test application.	Drug: BAY987521 Each 50 cm2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm2 test application. (Formulation Code:Z09-054)

Arm

Intervention/Treatment

Experimental: BAY987521

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.

Drug: BAY987521

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:Z09-054)

Outcome Measures

Primary Outcome Measures

Minimal Erythema Dose (MED) [Up to 15 minutes]
Minimal Persistent Pigment Darkening Dose (MPPD) [Up to 15 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 (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)

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Union	New Jersey	United States	07083

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT02936557

Other Study ID Numbers:

19205

First Posted:

Oct 18, 2016

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 13, 2018