check_circleStudy Completed

Sunscreen agents

Bayer Identifier:

18322

ClinicalTrials.gov Identifier:

NCT02885805

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sun Protection Factor (SPF) efficacy Assay

Trial purpose

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Key Participants Requirements

Sex

Both

Age

18 - 70 Years
  • - Fitzpatrick Skin Type I, II and/or 111 for UVB testing; Fitzpatrick Skin Type II, 111 and/or IV for UVA testing.
    - Sex: Male or female.
    - Age: 18-70 years.
    - Good health as determined from the HRL SHF.
    - Signed and dated lnformed Consent Form.
    - Signed and dated HIPAA Form.
    - An unambiguous MED or MPPD

Trial summary

Enrollment Goal
11
Trial Dates
June 2015 - July 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987516
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Union, 07083, United States

Primary Outcome

  • Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion
    The subsites on each of the protected test sites [test sunscreen and/or Control] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle [3"'] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.
    date_rangeTime Frame:
    up to 24 hours post-exposure
    enhanced_encryption
    Safety Issue:
    No
  • Sun Protection Factor (SPF) efficacy on the skin of human subjects after a total of 2 hours of water Immersion
    The subsites on each of the protected test sites [test sunscreen and/or Control] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle [3"'] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.
    date_rangeTime Frame:
    up to 24 hours post-exposure
    enhanced_encryption
    Safety Issue:
    No

Trial design

Sun Protection Factor (SPF) efficacy Assay
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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