Sunscreening AgentsNCT04749459

Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms

A study testing ChapStick Moisturizer, Strawberry Flavor, ChapStick Moisturizer, Classic Flavor and ISO 24444:2010 P2 Standard Reference Sunscreen in people with Sunscreening Agents, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Sunscreening Agents
What is being tested?: ChapStick Moisturizer, Strawberry Flavor, ChapStick Moisturizer, Classic Flavor and ISO 24444:2010 P2 Standard Reference Sunscreen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 3 Mar 2021to 31 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

Show all 11Show fewer

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.

Who cannot join

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;

Show all 19Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Fairfield, New Jersey, 07004

Other trials in United States

About this study

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

Read the 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.

Conditions: Sunscreening Agents
Being tested: ChapStick Moisturizer, Strawberry Flavor, ChapStick Moisturizer, Classic Flavor, ISO 24444:2010 P2 Standard Reference Sunscreen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChapStick Moisturizer, Strawberry FlavorDrug
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.
ChapStick Moisturizer, Classic FlavorDrug
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.
ISO 24444:2010 P2 Standard Reference SunscreenDrug
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.

Study groups in NCT04749459
Study group	Role	What they receive
ChapStick Moisturizer, Classic Flavor	Experimental	This arm will include all the test sites on the participants back where ChapStick Classic Moisturizer (ANZ) will be applied. Receives: Drug: ChapStick Moisturizer, Classic Flavor
ChapStick Moisturizer, Strawberry Flavor	Experimental	This arm will include all the test sites on the participants back where ChapStick Strawberry Moisturizer (ANZ) will be applied. Receives: Drug: ChapStick Moisturizer, Strawberry Flavor
ISO 24444:2010 P2 Standard Sunscreen	Active comparator	This arm will include all the test sites on the participants back where ISO 24444:2010 P2 Standard Sunscreen will be applied. Receives: Drug: ISO 24444:2010 P2 Standard Reference Sunscreen

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Up to 24 hours post UVR exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202131 Mar 2021

First posted11 Feb 2021
Study start3 Mar 2021
Primary completion31 Mar 2021
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sunscreening AgentsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04749459
Sponsor's protocol ID: 215232
Status last verified: Jan 2022
First submitted: 7 Feb 2021
Last updated: 16 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin

All Sunscreening Agents trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04749459
Acronym / sponsor ID: 215232
Conditions: Sunscreening Agents
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Mar 2021 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 11 Feb 2021 (actual)
Results: Posted 16 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ChapStick Moisturizer, Classic Flavor	Experimental	Drug: ChapStick Moisturizer, Classic FlavorThis arm will include all the test sites on the participants back where ChapStick Classic Moisturizer (ANZ) will be applied.
ChapStick Moisturizer, Strawberry Flavor	Experimental	Drug: ChapStick Moisturizer, Strawberry FlavorThis arm will include all the test sites on the participants back where ChapStick Strawberry Moisturizer (ANZ) will be applied.
ISO 24444:2010 P2 Standard Sunscreen	Active comparator	Drug: ISO 24444:2010 P2 Standard Reference SunscreenThis arm will include all the test sites on the participants back where ISO 24444:2010 P2 Standard Sunscreen will be applied.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (19 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChapStick Moisturizer, Strawberry FlavorA 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.	Drug	ChapStick Moisturizer, Strawberry Flavor
ChapStick Moisturizer, Classic FlavorA 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.	Drug	ChapStick Moisturizer, Classic Flavor
ISO 24444:2010 P2 Standard Reference SunscreenA 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.	Drug	ISO 24444:2010 P2 Standard Sunscreen

Primary outcome

Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Time frame: 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).

Results and safety

Results posted to the registry on 16 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	14	14

Primary outcome: Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values

Time frame: Up to 24 hours post UVR exposure. Mean (Standard Deviation). Unit: Ratio

Measure	CSM Classic n = 11	P2 Control Standard (vs. CSM Classic) n = 11	CSM Strawberry Flavor n = 10	P2 Control Standard (vs. CSM Strawberry Flavor) n = 10
Value	17.3 (3.5)	17.9 (4.4)	19.3 (4.5)	18.4 (4.1)

Population analysed: All randomized participants who received study treatments (test and control standard) and provided valid SPFi values.

Adverse events

Time frame: From screening until 14 days after last dose administration of trial product (Up to 29 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CSM Classic	0 of 12 (0%)	0 of 12 (0%)	0 of 12
P2 Control Standard (vs. CSM Classic)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
CSM Strawberry Flavor	0 of 10 (0%)	0 of 10 (0%)	0 of 10
P2 Control Standard (vs. CSM Strawberry Flavor)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
All Study Participants	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Sunscreening Agents

Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values (time frame: Up to 24 hours post UVR exposure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04749459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.