Study Completed

Sunscreening Agent

Bayer Identifier:

18616

ClinicalTrials.gov Identifier:

NCT02788162

EudraCT Number:

Not Available

EU CT Number:

Not Available

18616 - 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 (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.

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 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

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