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

NCT01001975 | Completed Phase 3 Results

• 3 other identifiers: 18119SR09-15P08236
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sun Protection

Keywords

Sunscreens

Outcome Measures

Primary Outcomes (2)

• Determination of Sunscreen Protection Factor (SPF)

  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).

  16 to 24 hours post-exposure

• Determination of Ultraviolet A Protection Factor (PFA)

  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).

  2 to 4 hours post-exposure

Study Arms (2)

SPF Testing

EXPERIMENTAL

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; Drug: Sunscreen Test Code: V53-030; Drug: Standard SPF 4 Sunscreen

UVA Protection Testing

EXPERIMENTAL

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; Drug: Sunscreen Test Code: V53-030

Interventions

Sunscreen Test Code: V53-028 DRUG

Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole

SPF Testing; UVA Protection Testing

Sunscreen Test Code: V53-030 DRUG

Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone

SPF Testing; UVA Protection Testing

Standard SPF 4 Sunscreen DRUG

8% Homosalate Standard SPF 4 Sunscreen

SPF Testing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharpe & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 11, 2015
• Results First Posted: December 7, 2010

Record last verified: 2015-02