check_circleStudy Completed

sunscreening agents

Bayer Identifier:

19206

ClinicalTrials.gov Identifier:

NCT02936570

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sun Protection Factor Assay (SPF Assay 206/2016)

Trial purpose

To evaluate the Sun Protection Factor efficacy on human skin.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years
  • - 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.

Trial summary

Enrollment Goal
5
Trial Dates
October 2016 - November 2016
Phase
N/A
Could I Receive a placebo
No
Products
BAY987521
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Union, 07083, United States

Primary Outcome

  • Minimal Erythema Dose (MED)
    date_rangeTime Frame:
    Up to 15 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Minimal Persistent Pigment Darkening Dose (MPPD)
    date_rangeTime Frame:
    Up to 15 minutes
    enhanced_encryption
    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
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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