Sunscreening Agents
Conditions
Brief summary
The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.
Detailed description
A single-center, randomized, controlled, intra-individual comparison, open label clinical study to determine the 8-hour moisturization efficacy of a sunscreen lip balm. Skin hydration will be assessed before (Baseline) and after (2, 4, 6 and 8 hours post-treatment) a single treatment with test product, compared to 'no treatment' as control, using a corneometer. Study treatments will be randomly assigned to 2 test sites delineated on the skin of the participant's volar forearms (one test site on each arm). A 1-week conditioning phase will precede the test day, during which participants will use the soap provided for personal washing.
Interventions
DRUGCLM Original
Sunscreen lip balm.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must provide a signed and dated, legally effective, informed consent document, which indicates they have been informed of, and understand, all pertinent aspects of the study, before any study procedures are performed (in conformance with 21 CFR Part 50: 'Protection of Human Subjects.') * Participant must provide relevant details of their medical history and current/recent medications and treatments * Participant has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164 * Participant must have completed a Photo Release Form * Participant must be able to read, write, speak and understand English * Participant must be in good general health * Participant must have a valid form of personal identification * Male and female participants of child-bearing potential must agree to use a highly effective method of contraception for the duration of the study and for 14 days after treatment application \[Note: A participant is considered to be of child-bearing potential if, in the opinion of the Principle Investigator (PI), they are biologically capable of having children and sexually active\] * Participant must agree to be sequestered in the environmental chamber at the clinical site (temperature 21 degree Celsius \[C\] +/- 2 degree C, relative humidity \[RH\] 50 percent (%) +/- 10%) for the duration of the test day (approximately 9.5 hours) * Participant must agree to bring their own food (dry) and beverages to be consumed on the test day (Visit 2) while sequestered in the environmental chamber * Participant must agree not to consume hot or very cold food/beverages on the test day (Visit 2) while sequestered in the environmental chamber * Participant must agree to use the non-moisturizing soap provided for all personal washing during the conditioning phase of the study * Participant must agree to wear loose clothing for ease of access to the test sites (arms) and/or sleeves that can be easily rolled up * Participant must agree not to introduce any new cosmetic/toiletry products into their personal care regimen during the study * Participant must agree to refrain from any physical effort which might result in thermal regulation by sweating (for example, exercise class, rapid climbing of flights of stairs, jogging, cycling, brisk walking) for at least 2 hours prior to arriving the test day (Visit 2) * Participant must agree to refrain from prolonged or excessive ultraviolet (UV) exposure (for example, sun-bathing, tanning beds) for the duration of the study * Participant should be dependable and able to follow directions as outlined in the protocol and Informed Consent Form (ICF)
Exclusion criteria
* Participant with scheduled or planned Covid-19 vaccination during likely dates of study participation * Female participant who is pregnant, planning to become pregnant during the study, or breastfeeding (self-reported) * Participant with a history of sensitivity to any ingredient of the test material or skin marker pen, or latex; or any known sensitivities/allergies, including but not limited to cosmetic/toiletry products and topically applied skin treatment products/drugs * Participant with a history of an acute or chronic dermatologic, medical and/or physical condition that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation (Note: dry skin is not an exclusion per se; however, a participant with a level of dryness on the skin of the volar forearms that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation should be excluded) * Participant with a history of skin cancer, or currently undergoing treatment for active cancer of any kind * Participant with diabetes * Participant with a planned medical treatment/vaccination during the study that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation * Participant with a planned hospitalization during the study * Participant who is currently using, or has used in the past week, any systemic or topical corticosteroid, non-steroid anti-inflammatory drug, antihistamine, sympathomimetic, and/or vasoconstrictor or any other medication that would, in the opinion of the investigator, confound study outcomes or increase the risk associated with participation * Participant who is unwilling to cease use of personal care products (for example, moisturizers, lotions, sunscreens, sunless tanners) and/or topical medications at the test sites for the duration of the study * Participant who has had extensive UV exposure within 3 weeks of Screening (Visit 1) * Participant with visual signs of irritation, sunburn, rashes, scratches, burn marks, scarring at the test sites that would interfere with corneometry measurements * Participant with excessive hair at the test sites that would interfere with corneometry measurements * Participant who has participated in a study involving the arms as a test site, or any other type of clinical study, within three weeks of screening (Visit 1) * Participant who is an employee/contractor or immediate family member of the PI, study site or Sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Baseline (Pre-treatment), 2, 4, 6 and 8 hours post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Improved Corneometer Measurement | 2, 4, 6 and 8 hours post-treatment | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at single center in United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 51.8 Years STANDARD_DEVIATION 14.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | 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 |
| Test Product | Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Baseline | 23.1 Arbitrary units | Standard Deviation 5.6 |
| Control (No Treatment) | Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Change from baseline 8 hours post-treatment | 1.0 Arbitrary units | Standard Deviation 2 |
| Control (No Treatment) | Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Baseline | 23.3 Arbitrary units | Standard Deviation 5.4 |
| Control (No Treatment) | Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Change from baseline 2 hours post-treatment | 0.1 Arbitrary units | Standard Deviation 1.9 |
| Control (No Treatment) | Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Change from baseline 4 hours post-treatment | 0.9 Arbitrary units | Standard Deviation 1.7 |
| Control (No Treatment) | Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint | Change from baseline 6 hours post-treatment | 1.1 Arbitrary units | Standard Deviation 1.8 |
Comparison: Pairwise comparison between Treated and Untreated sites 2 hours post-treatmentp-value: <0.000195% CI: [6.6, 8.8]ANCOVA
Comparison: Pairwise comparison between Treated and Untreated sites 4 hours post-treatment.p-value: <0.000195% CI: [5.8, 7.9]ANCOVA
Comparison: Pairwise comparison between Treated and Untreated sites 6 hours post-treatment.p-value: <0.000195% CI: [4, 6.2]ANCOVA
Comparison: Pairwise comparison between Treated and Untreated sites 8 hours post-treatment.p-value: <0.000195% CI: [3.6, 5.8]ANCOVA
Secondary
Percentage of Participants With Improved Corneometer Measurement
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.
Time frame: 2, 4, 6 and 8 hours post-treatment
Population: Primary analysis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Product | Percentage of Participants With Improved Corneometer Measurement | 2 hours post-treatment | 97.2 Percentage of participant |
| Test Product | Percentage of Participants With Improved Corneometer Measurement | 4 hours post-treatment | 100 Percentage of participant |
| Test Product | Percentage of Participants With Improved Corneometer Measurement | 6 hours post-treatment | 97.2 Percentage of participant |
| Test Product | Percentage of Participants With Improved Corneometer Measurement | 8 hours post-treatment | 100 Percentage of participant |
| Control (No Treatment) | Percentage of Participants With Improved Corneometer Measurement | 8 hours post-treatment | 63.9 Percentage of participant |
| Control (No Treatment) | Percentage of Participants With Improved Corneometer Measurement | 2 hours post-treatment | 44.4 Percentage of participant |
| Control (No Treatment) | Percentage of Participants With Improved Corneometer Measurement | 6 hours post-treatment | 72.2 Percentage of participant |
| Control (No Treatment) | Percentage of Participants With Improved Corneometer Measurement | 4 hours post-treatment | 63.9 Percentage of participant |