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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02930772
Other study ID # 19201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2016
Est. completion date November 3, 2016

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the Sun Protection Factor efficacy on human skin.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date November 3, 2016
Est. primary completion date November 3, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY987516
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: Z46-100)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimal Erythema Dose (MED) Up to 15 minutes
Primary Minimal Persistent Pigment Darkening Dose (MPPD) Up to 15 minutes
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