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Sun Protection Factor - Assay (SPF Assay)

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Bayer

Status

Completed

Conditions

Sunscreening Agent

Treatments

Drug: Coppertone (BAY 987517)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To evaluate the Sun Protection Factor efficacy on human skin.

Enrollment

6 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 unambiguous MED 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 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 (BAY 987517)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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