Trial Outcomes & Findings for Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms (NCT NCT04749459)

Results Overview

Arithmetic 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 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Up to 24 hours post UVR exposure

Results posted on

2022-03-16

Participant Flow

The study was conducted at single center in United States.

Total 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total,12 participants were treated with CSM Classic (12 test sites);10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset due to invalid data.

Participant milestones

Participant milestones
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer \[CSM\] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters \[cm\^2\] test site (2.00 +/- 0.05 mg/cm\^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
Overall Study STARTED	14
Overall Study CSM Classic	12
Overall Study CSM Strawberry Flavor	10
Overall Study P2 Control Standard	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=14 Participants Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer \[CSM\] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters \[cm\^2\] test site (2.00 +/- 0.05 mg/cm\^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product).
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=14 Participants
Age, Categorical >=65 years	3 Participants n=14 Participants
Sex: Female, Male Female	7 Participants n=14 Participants
Sex: Female, Male Male	7 Participants n=14 Participants

PRIMARY outcome

Timeframe: Up to 24 hours post UVR exposure

Population: All randomized participants who received study treatments (test and control standard) and provided valid SPFi values.

Arithmetic 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 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard).