Sunscreening Agents
Conditions
Brief summary
The aim of this study is to determine the SPF of two test materials ChapStick Moisturizer, Classic Flavor and ChapStick Moisturizer, Strawberry Flavor using the methodology described in the International Standard Test Method. This static methodology also meets the requirements of the Australia/New Zealand standard.
Detailed description
A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of two ChapStick sunscreen-containing lip balms as per ISO 24444:2010. For each participant, 4 test sites will have a random assignment number for up to two test materials, control standard, and minimal erythemal dose of unprotected skin (MEDu), with at least 3 of the test sites being utilized for application. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.
Interventions
DRUGChapStick Moisturizer, Strawberry Flavor
A single topical application of ChapStick Moisturizer, Strawberry Flavor will be applied to the appropriate 40 square centimeter (cm\^2) test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 milligram per centimeter square (mg/cm\^2), using 80 +/-2 milligrams (mg) of material.
DRUGChapStick Moisturizer, Classic Flavor
A single topical application of ChapStick Moisturizer, Classic Flavor will be applied to the appropriate 40 cm\^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm\^2, using 80 +/-2 mg of material.
DRUGISO 24444:2010 P2 Standard Reference Sunscreen
A single topical application of ISO 24444:2010 P2 Standard Sunscreen will be applied to the appropriate 40 cm\^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm\^2, using 80 +/-2 mg of material.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must read and execute an informed consent document (that includes a HIPAA statement) indicating that the participant has been informed of all pertinent aspects of the trial before any assessment is performed; * Participant must complete a Medical History Form (MHF) prior to their trial initiation; * Participant must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures; * Participant must agree not to expose their back to additional sunlight or tanning beds, as either can alter the test results; * Participant must agree not to apply any topical skin-care product to the test sites during this trial; * Male or female participants of childbearing potential must agree to use a highly effective method of contraception throughout the trial and for 14 days after the last application of assigned treatment. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active; * Female participants of childbearing potential must be willing to comply with urine pregnancy testing requirements prior to initiation of trial testing procedures and as may be required for the duration of the trial; * Participant must be considered dependable and capable of understanding and following directions; * Participant must have self-perceived Fitzpatrick skin phototype I, II, or III: Skin Phototype Sunburn and Tanning History I Always burn easily; never tans II Always burns easily; tans minimally III Burns moderately; tans gradually; and * Participant must have an Individual Typology Angle value \>28 degrees, determined by the Testing Facility by colorimetric methods, within 1 week of trial participation.
Exclusion criteria
* Participant is in ill health as determined by the Principal Investigator; * Participant is an employee of the Clinical Division of the investigational site or a member of their immediate family; * Participant is a GSK CH employee directly involved in the conduct of the trial or a member of their immediate family; * Female participant is pregnant or intending to become pregnant over the duration of the trial or any female participant of childbearing potential who fails to produce a negative urine pregnancy test; * Female participant who is lactating (self-reported); * Participant using medication with photo-sensitizing potential; * Participant has a history of adverse reactions or hypersensitivity to azo dyes, cosmetics, OTC drugs, or other topical personal care products; * Participant taking medications other than birth control that could influence the purpose, integrity or outcome of the trial; * Participant has used topical or systemic steroids, antihistamines, or antibiotics within 7 days of trial initiation or during the trial; * Participant has used anti-inflammatory medications within 7 days of trial initiation or during the trial, that in the opinion of the PI, could interfere with the trial; * Participant has used medication suspected of causing photobiological reactions (e.g., tetracyclines, thiazides, etc.), that has not been taken by the participant through a summer season; * Participant has a dermatological condition; * Participant has a history of abnormal response to the sun, or a condition such as lupus erythematosus or skin cancer; * Participant uses tanning beds frequently; * Participant whose test site was exposed to sunlight within the previous 4 weeks; * Participant has a sunburn, suntan, uneven skin color, visible skin disease, scarring, or tattoo that would interfere with evaluation of test results; Note: The presence of non-dysplastic nevi, blemishes, or moles will be acceptable if, in the PI's judgment, they will neither compromise the clinical trial, nor jeopardize a participant's safety. A participant with dysplastic nevi should be disqualified. * Participant has existing sun damage in the test site; * Participant has excessive hair in the test area and are unwilling to have it clipped; or * Participant whose test sites have been used for clinical testing in which they were exposed to ultraviolet radiation within the past 2 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | Up to 24 hours post UVR exposure | Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard). |
Countries
United States
Participant flow
Recruitment details
The study was conducted at single center in United States.
Pre-assignment details
Total 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total,12 participants were treated with CSM Classic (12 test sites);10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset due to invalid data.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Study participants were randomly assigned to receive a single topical application of 3 study treatments (ChapStick Moisturizer \[CSM\] Classic; CSM Strawberry Flavor; P2 Control Standard) or no treatment to 4 test sites on the back; 80 +/- 2 milligram (mg) product was applied to each 40 square centimeters \[cm\^2\] test site (2.00 +/- 0.05 mg/cm\^2). If there was space for only 3 test sites on the participant's back, only one of the two ChapStick products was evaluated. Test sites received a progressive sequence of timed ultraviolet radiation (UVR) exposures and were evaluated for erythema immediately after irradiation and 16-24 hours (hrs) later. A total of 14 participants were enrolled; up to 4 test sites on the back of each participant were randomized to treatment (2 test products, P2 Control Standard and 1 untreated site used to calculate MEDu). In total, 12 participants were treated with CSM Classic (12 test sites); 10 participants were treated with CSM Strawberry (10 test sites); 14 participants received P2 Control Standard (14 test sites). One participant was excluded from the final CSM Classic vs P2 Control dataset (invalid data: erythema in all sub-sites treated with the test product). | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 14 |
Outcome results
Primary
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard).
Time frame: Up to 24 hours post UVR exposure
Population: All randomized participants who received study treatments (test and control standard) and provided valid SPFi values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSM Classic | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 17.3 Ratio | Standard Deviation 3.5 |
| P2 Control Standard (vs. CSM Classic) | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 17.9 Ratio | Standard Deviation 4.4 |
| CSM Strawberry Flavor | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 19.3 Ratio | Standard Deviation 4.5 |
| P2 Control Standard (vs. CSM Strawberry Flavor) | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 18.4 Ratio | Standard Deviation 4.1 |