18791 - Sun Protection Factor Assay (SFP)

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Bayer

Status

Completed

Conditions

Sunscreening Agent

Treatments

Drug: Coppertone (BAY987517)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02682628
18791

Details and patient eligibility

About

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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
  • Signed and dated Informed Consent Form
  • Signed and dated HIPAA Form
  • An unbmbiguous 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 dianoses 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

BAY987517
Experimental group
Description:
Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, 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.
Treatment:
Drug: Coppertone (BAY987517)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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