Trial Outcomes & Findings for Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products (NCT NCT05124899)

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 = 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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

From 16 to 24 hours post UV exposure

Results posted on

2024-04-26

Participant Flow

The study was conducted at single center in United States.

Unit of analysis: back test sites

Participant milestones

Participant milestones
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of up to 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site; 80+/-2 milligrams (mg) product was applied to each 40 square centimeter(cm\^2) test site (2.00+/-0.05 mg/cm\^2). 15-minutes (mins) after test product application, the participant was seated in a water tub, with their upper back submerged for four 20-mins immersions, each of which was followed by a 15-mins air drying period. After completing the final air-drying period, 80+/-2 mg (2.0 mg/cm\^2+/-0.05 mg/cm\^2) of the SPF standard (7 percent \[%\] Padimate-O and 3% Oxybenzone) was applied to its designated test site. 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. When one site was invalid the data set was removed from the SPF testing.
Overall Study STARTED	15 60
Overall Study CAP UnScented	10 10
Overall Study CAP Herbal Mint	12 12
Overall Study CAP Mountain Berry	8 8
Overall Study SPF Standard	15 15
Overall Study Untreated Sites	15 15
Overall Study COMPLETED	12 32
Overall Study NOT COMPLETED	3 28

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of up to 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site; 80+/-2 milligrams (mg) product was applied to each 40 square centimeter(cm\^2) test site (2.00+/-0.05 mg/cm\^2). 15-minutes (mins) after test product application, the participant was seated in a water tub, with their upper back submerged for four 20-mins immersions, each of which was followed by a 15-mins air drying period. After completing the final air-drying period, 80+/-2 mg (2.0 mg/cm\^2+/-0.05 mg/cm\^2) of the SPF standard (7 percent \[%\] Padimate-O and 3% Oxybenzone) was applied to its designated test site. 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. When one site was invalid the data set was removed from the SPF testing.
Overall Study Lost to Follow-up	3

Baseline Characteristics

Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants Study participants were randomly assigned to receive a single topical application of up to 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site; 80+/-2 mg product was applied to each 40 cm\^2 test site (2.00+/-0.05 mg/cm\^2). 15-mins after test product application, the participant was seated in a water tub, with their upper back submerged for four 20-mins immersions, each of which was followed by a 15-mins air drying period. After completing the final air-drying period, 80+/-2 mg (2.0 mg/cm\^2+/-0.05 mg/cm\^2) of the SPF standard (7% Padimate-O and 3% Oxybenzone) was applied to its designated test site. Test sites received a progressive sequence of timed UV radiation exposures and were evaluated for erythema immediately after irradiation and 16-24 hours later. When one site was invalid the data set was removed from the SPF testing.
Age, Customized <18 years	0 Participants n=12 Participants
Age, Customized 18 to 70 years	12 Participants n=12 Participants
Age, Customized >70 years	0 Participants n=12 Participants
Sex/Gender, Customized Female	6 Participants n=12 Participants
Sex/Gender, Customized Male	5 Participants n=12 Participants
Sex/Gender, Customized Unknown	1 Participants n=12 Participants

PRIMARY outcome

Timeframe: From 16 to 24 hours post UV exposure

Population: Data could not be collected for primary outcome: required number of valid datasets (\>=10) not achieved to calculate mean SPF

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 = 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).

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Haleon Response Center

HALEON

Phone: +44 7880 182593

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON 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