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Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED) (PFA and SPF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001975
First Posted: October 27, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole.

Condition Intervention Phase
Sun Protection Drug: Sunscreen Test Code: V53-028 Drug: Sunscreen Test Code: V53-030 Drug: Standard SPF 4 Sunscreen Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Determination of Sun Protection Factors (PFA and SPF) in Sunscreen Formulas Containing Combinations of Zinc Oxide and Avobenzone

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Determination of Sunscreen Protection Factor (SPF) [ Time Frame: 16 to 24 hours post-exposure ]
    Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).

  • Determination of Ultraviolet A Protection Factor (PFA) [ Time Frame: 2 to 4 hours post-exposure ]
    Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).


Enrollment: 10
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPF Testing
Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation [UVB] and UVA).
Drug: Sunscreen Test Code: V53-028
Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole
Drug: Sunscreen Test Code: V53-030
Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone
Drug: Standard SPF 4 Sunscreen
8% Homosalate Standard SPF 4 Sunscreen
Experimental: UVA Protection Testing
Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
Drug: Sunscreen Test Code: V53-028
Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole
Drug: Sunscreen Test Code: V53-030
Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 70 years of age
  • Have Fitzpatrick skin types I, II, or III
  • In good general health based on a medical history review
  • Be free of any acute or chronic illness/disease that might interfere with or increase risk of study participation
  • Be able to cooperate with the investigator and research staff
  • Be willing to have the test materials applied according to the protocol
  • Be capable of understanding and provide written informed consent

Exclusion Criteria:

  • Subjects with a history of adverse effects upon sun exposure
  • Subjects currently taking any medication that may alter the sunlight response or is a known photosensitizer
  • Subjects with a history of any form of cancer, lupus, psoriasis, rosacea, porphyria cutanea tarda, connective tissue disease, diabetes or any disease that would increase the risks associated with study participation
  • Subjects with an abnormal sensitivity to any sunscreen agent
  • Females who indicate that they are pregnant or nursing an infant during the period of the study
  • Subjects with excessive hair, blemishes, nevi, warts, moles, scars, sunburn, suntan or uneven pigmentation in the test areas
  • Subjects who have been administered an investigations drug or have participated in another SPF or PFA study within 30 days prior to this study
  • Subjects who are allergic to latex or latex products
  • Subjects who have any conditions that would make study participation inappropriate as determined by the investigator
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01001975     History of Changes
Other Study ID Numbers: 18119
SR09-15
P08236 ( Other Identifier: Merck )
First Submitted: October 23, 2009
First Posted: October 27, 2009
Results First Submitted: November 4, 2010
Results First Posted: December 7, 2010
Last Update Posted: October 12, 2017
Last Verified: February 2015

Keywords provided by Bayer:
Sunscreens

Additional relevant MeSH terms:
Sunscreening Agents
Zinc Oxide
Avobenzone
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents