Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm (NCT NCT05082376)

Results Overview

Corneometry is an instrumental technique. It uses a capacitance sensor to measure the dielectric constant of the stratum corneum which is directly proportional to the water content of the skin (skin hydration). Capacitance of the skin surface is expressed in arbitrary units of skin hydration; the higher value, the more hydrated (moist) the skin. The mean of 3 corneometer readings taken for each test site at each assessment timepoint (Baseline and 2-, 4-, 6- and 8-hours post-treatment) was calculated for each individual participant. Change from Baseline was calculated at each post-treatment timepoint as the post-treatment value minus the Baseline value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Baseline (Pre-treatment), 2, 4, 6 and 8 hours post-treatment

Results posted on

2024-04-19

Participant Flow

The study was conducted at single center in United States.

Two test sites on each participant's volar forearms (one site per arm) were randomized to treatment, either ChapStick Lip Moisturizer (CLM) Original (test product) or no treatment (control). Thirty-eight participants were enrolled. Two were lost to follow up during the conditioning phase, thus 36 eligible participants received study treatment.

Unit of analysis: Volar Forearm Sites

Participant milestones

Participant milestones
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of CLM Original (test product) or no treatment (control) to two 40 square centimeter (cm\^2) test sites delineated on the skin of their volar forearms. 80 +/- 2 milligrams (mg) CLM Original was applied to its assigned test site (2.00 +/- 0.05 mg/cm\^2); no treatment was applied to the test site on the opposing volar forearm. Skin hydration was assessed using corneometry (3 readings per test site at each timepoint), the higher the corneometer reading, the more hydrated the skin.
Overall Study STARTED	38 76
Overall Study Test Product (CLM Original)	36 36
Overall Study Control (No Treatment)	36 36
Overall Study COMPLETED	36 72
Overall Study NOT COMPLETED	2 4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Study participants were randomly assigned to receive a single topical application of CLM Original (test product) or no treatment (control) to two 40 square centimeter (cm\^2) test sites delineated on the skin of their volar forearms. 80 +/- 2 milligrams (mg) CLM Original was applied to its assigned test site (2.00 +/- 0.05 mg/cm\^2); no treatment was applied to the test site on the opposing volar forearm. Skin hydration was assessed using corneometry (3 readings per test site at each timepoint), the higher the corneometer reading, the more hydrated the skin.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=36 Participants Study participants were randomly assigned to receive a single topical application of CLM Original (test product) or no treatment (control) to two 40 square centimeter (cm\^2) test sites delineated on the skin of their volar forearms. 80 +/- 2 milligrams (mg) CLM Original was applied to its assigned test site (2.00 +/- 0.05 mg/cm\^2); no treatment was applied to the test site on the opposing volar forearm. Skin hydration was assessed using corneometry (3 readings per test site at each timepoint), the higher the corneometer reading, the more hydrated the skin.
Age, Continuous	51.8 Years STANDARD_DEVIATION 14.7 • n=36 Participants
Sex: Female, Male Female	28 Participants n=36 Participants
Sex: Female, Male Male	8 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline (Pre-treatment), 2, 4, 6 and 8 hours post-treatment

Population: Primary analysis population: all eligible participants who were randomized, received study treatment and provided at least one post-treatment efficacy assessment.

Corneometry is an instrumental technique. It uses a capacitance sensor to measure the dielectric constant of the stratum corneum which is directly proportional to the water content of the skin (skin hydration). Capacitance of the skin surface is expressed in arbitrary units of skin hydration; the higher value, the more hydrated (moist) the skin. The mean of 3 corneometer readings taken for each test site at each assessment timepoint (Baseline and 2-, 4-, 6- and 8-hours post-treatment) was calculated for each individual participant. Change from Baseline was calculated at each post-treatment timepoint as the post-treatment value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Test Product n=36 Participants All participants who received CLM Original at the assigned test site.	Control (No Treatment) n=36 Participants All participants who received no treatment at the assigned test site.
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint Baseline	23.1 Arbitrary units Standard Deviation 5.6	23.3 Arbitrary units Standard Deviation 5.4
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint Change from baseline 2 hours post-treatment	7.8 Arbitrary units Standard Deviation 4.3	0.1 Arbitrary units Standard Deviation 1.9
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint Change from baseline 4 hours post-treatment	7.7 Arbitrary units Standard Deviation 3.7	0.9 Arbitrary units Standard Deviation 1.7
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint Change from baseline 6 hours post-treatment	6.2 Arbitrary units Standard Deviation 3.4	1.1 Arbitrary units Standard Deviation 1.8
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint Change from baseline 8 hours post-treatment	5.6 Arbitrary units Standard Deviation 3.2	1.0 Arbitrary units Standard Deviation 2.0

SECONDARY outcome

Timeframe: 2, 4, 6 and 8 hours post-treatment

Population: Primary analysis population

Percentage of participants with improved corneometer measurement was calculated at each post-treatment timepoint as the number of participants who exhibited improvement (positive change) divided by the total number of participants included in the analysis.

Outcome measures

Outcome measures
Measure	Test Product n=36 Participants All participants who received CLM Original at the assigned test site.	Control (No Treatment) n=36 Participants All participants who received no treatment at the assigned test site.
Percentage of Participants With Improved Corneometer Measurement 2 hours post-treatment	97.2 Percentage of participant	44.4 Percentage of participant
Percentage of Participants With Improved Corneometer Measurement 4 hours post-treatment	100 Percentage of participant	63.9 Percentage of participant
Percentage of Participants With Improved Corneometer Measurement 6 hours post-treatment	97.2 Percentage of participant	72.2 Percentage of participant
Percentage of Participants With Improved Corneometer Measurement 8 hours post-treatment	100 Percentage of participant	63.9 Percentage of participant

Adverse Events

All Study 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

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