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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01001975
First received: October 23, 2009
Last updated: April 29, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Determination of Sunscreen Protection Factor (SPF) [ Time Frame: 16 to 24 hours post-exposure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01001975     History of Changes
Other Study ID Numbers: P08236, SR09-15
Study First Received: October 23, 2009
Results First Received: November 4, 2010
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Sunscreens

Additional relevant MeSH terms:
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014