Trial Outcomes & Findings for Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED) (NCT NCT01001975)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

16 to 24 hours post-exposure

Results posted on

2015-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Sun Protection Factor (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 Radiation A \[UVA\] and ultraviolet radiation B \[UVB\]).	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.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sun Protection Factor (SPF) Testing n=5 Participants 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 Radiation A \[UVA\] and ultraviolet radiation B \[UVB\]).	UVA Protection Testing n=5 Participants 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.	Total n=10 Participants Total of all reporting groups
Age, Continuous	42.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	38 years STANDARD_DEVIATION 12.6 • n=7 Participants	40.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 to 24 hours post-exposure

Population: Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of 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).

Outcome measures

Outcome measures
Measure	Sun Protection Factor (SPF) Testing n=5 Participants 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 Radiation A \[UVA\] and ultraviolet radiation B \[UVB\]).	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.
Determination of Sunscreen Protection Factor (SPF) V53-028	14.72 Score on a scale Standard Deviation 2.31	—
Determination of Sunscreen Protection Factor (SPF) V53-030	15.00 Score on a scale Standard Deviation 0.00	—

PRIMARY outcome

Timeframe: 2 to 4 hours post-exposure

Population: Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of 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).

Outcome measures

Outcome measures
Measure	Sun Protection Factor (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 Radiation A \[UVA\] and ultraviolet radiation B \[UVB\]).	UVA Protection Testing n=5 Participants 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.
Determination of Ultraviolet A Protection Factor (PFA) V53-028	—	11.60 Score on a scale Standard Deviation 2.01
Determination of Ultraviolet A Protection Factor (PFA) V53-030	—	10.50 Score on a scale Standard Deviation 1.12

Adverse Events

Sun Protection Factor (SPF) Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

UVA Protection Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharpe & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that no information based on the conduct (including the protocol, the data resulting from this study or the fact that this study is being conducted) will be released without prior written consent of the sponsor, unless this requirement is superceded by the State or Federal law.
Publication restrictions are in place

Restriction type: OTHER