Trial Outcomes & Findings for Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products (NCT NCT05109104)

Results Overview

SPF values for each test product and the SPF standard were first calculated for each individual participant:SPFi = MEDp/MEDuR (p=protected \[treated\] site; u=unprotected \[untreated\] site). The arithmetic mean SPF, standard deviation (SD) and standard error (SE) were then calculated separately for each test product and the SPF standard from valid SPFi data: SPF = (ΣSPFi)/n; SD = √\[(ΣSPFi\^2) - ((ΣSPFi)\^2/n) /(n-1))\]; SE = SD/√n (n = number participants providing valid test results). For SPF determination to be considered valid, in compliance with FDA Final Rule 2011, the mean SPF value of the SPF standard should fall within the SD range of the expected SPF (i.e.,16.3 ± 3.43 or 12.87 to 19.73). The MED is the lowest dose of UV radiation that produces the first perceptible erythema with clearly defined borders (covering more than 50% of the exposure site), 16 to 24 hours (hrs) after UV exposure administration.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

From 16 to 24 hours post UV exposure

Results posted on

2024-04-19

Participant Flow

The study was conducted at single center in United States.

Study participants were randomly assigned to receive a single topical application of each 4 study treatments (ChapStick Active Performance \[CAP\] UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site used to determine repeat unprotected Minimal Erythema Dose \[MEDuR\].

Unit of analysis: test sites on back

Participant milestones

Participant milestones
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of each 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site. Each product/untreated test site was delineated on a site on the participants back. Around 80 +/- 2 milligrams (mg) product was applied to each 40 square centimeter (cm\^2) test site (2.00 +/- 0.05 mg/cm\^2). Test sites received a progressive sequence of timed ultraviolet (UV) radiation exposures and were evaluated for erythema immediately after irradiation and 16-24 hours later. A total of 13 participants were enrolled; 11 received CAP UnScented (11 test sites, of which 1 became invalid); 11 received CAP Herbal Mint (11 test sites, of which 1 became invalid); 13 received CAP Mountain Berry (13 test sites, of which 2 became invalid); 13 received SPF Standard (13 test sites); and 13 participants with 13 untreated test sites (of which 1 became invalid).
Overall Study STARTED	13 61
Overall Study CAP UnScented	11 10
Overall Study CAP Herbal Mint	11 10
Overall Study CAP Mountain Berry	13 11
Overall Study SPF Standard	13 13
Overall Study Untreated	13 12
Overall Study COMPLETED	13 56
Overall Study NOT COMPLETED	0 5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=13 Participants Study participants were randomly assigned to receive a single topical application of each 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site. Each product/untreated test site was delineated on a site on the participants back. Around 80 +/- 2 mg product was applied to each 40 cm\^2 test site (2.00 +/- 0.05 mg/cm\^2). Test sites received a progressive sequence of timed UV radiation exposures and were evaluated for erythema immediately after irradiation and 16-24 hours later. A total of 13 participants were enrolled; 11 received CAP UnScented (11 test sites, of which 1 became invalid); 11 received CAP Herbal Mint (11 test sites, of which 1 became invalid); 13 received CAP Mountain Berry (13 test sites, of which 2 became invalid); 13 received SPF Standard (13 test sites); and 13 participants with 13 untreated test sites (of which 1 became invalid).
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Sex: Female, Male Female	3 Participants n=13 Participants
Sex: Female, Male Male	10 Participants n=13 Participants

PRIMARY outcome

Timeframe: From 16 to 24 hours post UV exposure

Population: Analysis Population: all randomized participants who received study treatment and provided valid results. Only those participants who have valid sites were analyzed.

SPF values for each test product and the SPF standard were first calculated for each individual participant:SPFi = MEDp/MEDuR (p=protected \[treated\] site; u=unprotected \[untreated\] site). The arithmetic mean SPF, standard deviation (SD) and standard error (SE) were then calculated separately for each test product and the SPF standard from valid SPFi data: SPF = (ΣSPFi)/n; SD = √\[(ΣSPFi\^2) - ((ΣSPFi)\^2/n) /(n-1))\]; SE = SD/√n (n = number participants providing valid test results). For SPF determination to be considered valid, in compliance with FDA Final Rule 2011, the mean SPF value of the SPF standard should fall within the SD range of the expected SPF (i.e.,16.3 ± 3.43 or 12.87 to 19.73). The MED is the lowest dose of UV radiation that produces the first perceptible erythema with clearly defined borders (covering more than 50% of the exposure site), 16 to 24 hours (hrs) after UV exposure administration.