Sunscreening AgentsNCT05082376
Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm
A study testing CLM Original in people with Sunscreening Agents, run by HALEON at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application. 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?
- CLM Original
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 11 Nov 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 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Piscataway, New Jersey, 08854
About this study
Official title: A Clinical Study to Evaluate the 8-Hour Moisturization Efficacy of an Over-The-Counter Sunscreen Lip Balm After a Single Application
The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.
Read the 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.
- Conditions
- Sunscreening Agents
- Being tested
- CLM Original
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLM OriginalDrug
Sunscreen lip balm.
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Single topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg/centimeter^2) of ChapStick Lip Moisturizer (CLM) Original will be applied to the assigned test site using a fingercot. The test product will be evenly spread over the test site using light pressure. Receives: Drug: CLM Original |
| Control Arm | No intervention | No treatment will be applied to the assigned control site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-treatment), 2, 4, 6 and 8 hours post-treatment
Secondary outcomes (1)
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.
Measured: 2, 4, 6 and 8 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Nov 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 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 HALEONThe 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082376
- Sponsor's protocol ID
- 218004
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2021
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the 8-Hour Moisturization Efficacy of an Over-The-Counter Sunscreen Lip Balm After a Single Application
- ClinicalTrials.gov ID
- NCT05082376
- Acronym / sponsor ID
- 218004
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Drug: CLM OriginalSingle topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg/centimeter^2) of ChapStick Lip Moisturizer (CLM) Original will be applied to the assigned test site using a fingercot. The test product will be evenly spread over the test site using light pressure. |
| Control Arm | No intervention | –No treatment will be applied to the assigned control site. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| CLM OriginalSunscreen lip balm. | Drug | Test Arm |
Primary outcome
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint
Time frame: 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.
1 secondary outcome
Percentage of Participants With Improved Corneometer Measurement
Time frame: 2, 4, 6 and 8 hours post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Sunscreening Agents
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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
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A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
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Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
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Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
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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?
A study testing CLM Original in people with Sunscreening Agents, run by HALEON at 1 site in United States.
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 17 inclusion and 15 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 19 Apr 2024. 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 19 Apr 2024). 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?
Mean Change From Baseline in Corneometry Value at Each Post-treatment Timepoint (time frame: Baseline (Pre-treatment), 2, 4, 6 and 8 hours post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.