Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm Product (NCT NCT05109117)
NCT ID: NCT05109117
Last Updated: 2024-03-29
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.
COMPLETED
NA
39 participants
Baseline (pre-treatment), 2, 4, 6 and 8 hours post-treatment
2024-03-29
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 Active Performance (CAP) Unscented (test product) or no treatment (control).
Unit of analysis: Volar forearm test sites
Participant milestones
| Measure |
All Study Participants
Study participants were randomly assigned to receive a single topical application of CAP Unscented (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) CAP Unscented 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.
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|---|---|
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Overall Study
STARTED
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38 76
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Overall Study
Safety Population
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37 74
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Overall Study
Test Product (CAP UnScented)
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36 36
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Overall Study
Control (No Treatment)
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36 36
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Overall Study
COMPLETED
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36 72
|
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Overall Study
NOT COMPLETED
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2 4
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Reasons for withdrawal
| Measure |
All Study Participants
Study participants were randomly assigned to receive a single topical application of CAP Unscented (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) CAP Unscented 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.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Discontinued for non-compliance
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1
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Baseline Characteristics
Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm Product
Baseline characteristics by cohort
| Measure |
All Study Participants
n=37 Participants
Study participants were randomly assigned to receive a single topical application of CAP Unscented (test product) or no treatment (control) to two 40 cm\^2 test sites delineated on the skin of their volar forearms. 80 +/- 2 mg CAP Unscented 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.
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|---|---|
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Age, Continuous
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55.6 Years
STANDARD_DEVIATION 12.3 • n=37 Participants
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Sex: Female, Male
Female
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25 Participants
n=37 Participants
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Sex: Female, Male
Male
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12 Participants
n=37 Participants
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PRIMARY outcome
Timeframe: Baseline (pre-treatment), 2, 4, 6 and 8 hours post-treatmentPopulation: Primary analysis population: included 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
| Measure |
Test Product
n=36 Volar forearm test sites
All participants who received CAP Unscented at the assigned test site and provided at least one post-treatment efficacy assessment.
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Control (No Treatment)
n=36 Volar forearm test sites
All participants who received no treatment at the assigned test site and provided at least one post-treatment efficacy assessment.
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|---|---|---|
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Mean Change From Baseline in Corneometer Measurements
Baseline
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23.5 Arbitrary units
Standard Deviation 5.7
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24.2 Arbitrary units
Standard Deviation 6.0
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Mean Change From Baseline in Corneometer Measurements
Change from Baseline 2 hours post-treatment
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2.4 Arbitrary units
Standard Deviation 4.2
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-0.6 Arbitrary units
Standard Deviation 2.3
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Mean Change From Baseline in Corneometer Measurements
Change from Baseline 4 hours post-treatment
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1.7 Arbitrary units
Standard Deviation 3.5
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-0.1 Arbitrary units
Standard Deviation 2.7
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Mean Change From Baseline in Corneometer Measurements
Change from Baseline 6 hours post-treatment
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2.0 Arbitrary units
Standard Deviation 5.3
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0.0 Arbitrary units
Standard Deviation 2.6
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Mean Change From Baseline in Corneometer Measurements
Change from Baseline 8 hours post-treatment
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1.0 Arbitrary units
Standard Deviation 3.3
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-0.2 Arbitrary units
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: 2, 4, 6 and 8 hours post-treatmentPopulation: 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
| Measure |
Test Product
n=36 Volar forearm test sites
All participants who received CAP Unscented at the assigned test site and provided at least one post-treatment efficacy assessment.
|
Control (No Treatment)
n=36 Volar forearm test sites
All participants who received no treatment at the assigned test site and provided at least one post-treatment efficacy assessment.
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|---|---|---|
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Percentage of Participants With Improved Corneometer Measurement
2 hours post-treatment
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69.4 Percentage of participant
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38.9 Percentage of participant
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Percentage of Participants With Improved Corneometer Measurement
4 hours post-treatment
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66.7 Percentage of participant
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44.4 Percentage of participant
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Percentage of Participants With Improved Corneometer Measurement
6 hours post-treatment
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66.7 Percentage of participant
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55.6 Percentage of participant
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Percentage of Participants With Improved Corneometer Measurement
8 hours post-treatment
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66.7 Percentage of participant
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50.0 Percentage of participant
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Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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