Last updated: 01/19/2022 11:00:06
Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Clinical Evaluation of Sunscreen Efficacy with the Sun Protection Factor Assay and Calculation of the Label SPF - ISO 24444 (2010) Test Method & Australia/New Zealand Test Method
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Timeframe: Up to 24 hours post UV exposure
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
14
Primary completion date:
2021-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sunscreening Agents
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2021 to March 2021
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 70 Years
Accepts 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;
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Fairfield, New Jersey, United States, 07004
Status
Study Complete
Study documents
Protocol and statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2021-31-03
Actual study completion date
2021-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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