Trial Outcomes & Findings for Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products (NCT NCT05085327)

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 = (∑SPFi)/n; SD = √\[(∑SPFi\^2) - ((∑SPFi)\^2/n) / (n-1))\]; SE = SD/√n (n = no. 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

11 participants

Primary outcome timeframe

From 16 to 24 hours post UV exposure

Results posted on

2024-03-25

Participant Flow

The study was conducted at single center in United States.

Five test sites on each participant's back were randomized to treatment (3 test products; Sun Protection Factor (SPF) standard; one untreated site used to determine repeat unprotected MED \[MEDuR\]). A total of 11 participants were enrolled; 11 received ChapStick Lip Moisturizer (CLM) Original (11 test sites);10 received CLM Mint (10 sites); 11 received CLM Black Cherry (11 test sites); 11 received SPF Standard (11 test sites).

Unit of analysis: back sites

Participant milestones

Participant milestones
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of 4 study treatments (CLM Original; CLM Mint; CLM Black Cherry; SPF Standard) or no treatment to 5 of the 8 test sites delineated on the skin of their back; 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 11 participants were enrolled; 11 received CLM Original (11 test sites); 10 received CLM Mint (10 test sites); 11 received CLM Black Cherry (11 test sites); 11 received the SPF Standard (11 test sites). The mean static SPF of the test product (CLM Original and CLM Black Cherry Flavour) were calculated from the 10 valid datasets for the test product from 11 participants.
Overall Study STARTED	11 11
Overall Study CLM Original	11 11
Overall Study CLM Mint	10 10
Overall Study CLM Black Cherry	11 11
Overall Study SPF Standard	11 11
Overall Study COMPLETED	11 11
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=11 Participants Study participants were randomly assigned to receive a single topical application of 4 study treatments (CLM Original; CLM Mint; CLM Black Cherry; SPF Standard) or no treatment to 5 of the 8 test sites delineated on the skin of their back; 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 11 participants were enrolled; 11 received CLM Original (11 test sites); 10 received CLM Mint (10 test sites); 11 received CLM Black Cherry (10 test sites); 11 received the SPF Standard (11 test sites). The mean static SPF of the test product (CLM Original and CLM Black Cherry Flavour) were calculated from the 10 valid datasets for the test product from 11 participants.
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants
Sex: Female, Male Female	7 Participants n=11 Participants
Sex: Female, Male Male	4 Participants n=11 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.

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 = (∑SPFi)/n; SD = √\[(∑SPFi\^2) - ((∑SPFi)\^2/n) / (n-1))\]; SE = SD/√n (n = no. 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.