Study Completed

Sunscreening Agents

Bayer Identifier:

18611

ClinicalTrials.gov Identifier:

NCT02760563

EudraCT Number:

Not Available

EU CT Number:

Not Available

18611 - Sun Protection Factor Assay

Trial purpose

To evaluate the Sun Protection Factor efficacy on human skin.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years

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 Form (Health Insurance Portability and Accountability Act).
- 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 diagnosed 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.

Trial summary

Enrollment Goal

Trial Dates

October 2015 - October 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987517

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Union, 07083, United States

Primary Outcome

Minimal Erythema Dose (MED)
Time Frame:
Up to 15 minutes
Safety Issue:
No
Minimal Persistent Pigment Darkening Dose (MPPD)
Time Frame:
Up to 15 minutes
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.