Trial Outcomes & Findings for Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream (NCT NCT03136107)

Last Updated: 2019-04-19

Results Overview

Arithmetical mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation (SPFi = MEDp/MEDu). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Up to 24 hours post UV exposure

Results posted on

2019-04-19

Participant Flow

All the participants were randomized at one center in Germany.

Participant milestones

Participant milestones
Measure	All Participants There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule. All participants who were randomized to receive the study treatments were included.
Overall Study STARTED	26
Overall Study Test Product	26
Overall Study Reference Product	26
Overall Study Negative Control	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule. All participants who were randomized to receive the study treatments were included.
Overall Study Other (Not specified)	1

Baseline Characteristics

Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=26 Participants Baseline population included safety population (N=26), safety population included all participants randomized and received any application of the study products.There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule.
Age, Continuous	45.7 Years STANDARD_DEVIATION 14.27 • n=93 Participants
Sex: Female, Male Female	23 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 24 hours post UV exposure

Population: Intent to treat (ITT, N= 25) all valid participants data with no major protocol deviations were included in the SPF calculations. All participants exposed to Ultra Violet (UV) radiation were included the safety population, irrelevant of whether they successfully complete the study.

Outcome measures

Outcome measures
Measure	Test Product n=25 Participants This arm included all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) was applied.	Reference Product n=25 Participants This arm included all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) was applied.
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value	19.4 Ratio (unit less) Interval 16.24 to 22.63	14.0 Ratio (unit less) Interval 11.7 to 16.36

Adverse Events

Test Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Participants

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

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER