Sunscreening AgentsNCT05085327

Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products

A study testing ChapStick Lip Moisturizer Original, ChapStick Lip Moisturizer Mint and ChapStick Lip Moisturizer Black Cherry in people with Sunscreening Agents, run by HALEON 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

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Trial summary

The purpose of this study is to determine the static SPF of three sunscreen products (ChapStick Lip Moisturizer [CLM] Original, CLM Mint Flavour and CLM Black Cherry Flavour) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011). 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 Lip Moisturizer Original, ChapStick Lip Moisturizer Mint and ChapStick Lip Moisturizer Black Cherry
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2021to 4 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 all pertinent aspects of the study, before any study procedures are performed.
Participant must provide relevant details of their medical history and current/recent medications and treatments (self-reported).
Participant must have completed an annual Health Insurance Portability and Accountability Act (HIPAA) Authorization form.
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 uniform skin color over the test area (skin of the back between the shoulder blades and above the waistline) and an Individual Typology Angle (ITA) value more than (>)28 degree.
Participant must have Fitzpatrick Skin Type I, II or III
Participant must have sufficient area of suitable skin on their back for at least six 40 centimeter square (cm^2) test sites.
Willing to have body hair clipped by a technician if participant has excessive hair in the test area.
Participant must have a valid form of personal identification (photo identity [ID], driver's license, passport, permanent resident card, military ID card; forms cannot be expired).
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 their last treatment application. (Note: 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.

Who cannot join

Participant with a scheduled or planned Covid-19 vaccination during likely dates of study participation.
Participant with a history of abnormal response to sunlight/UV radiation.
Participant with a history of sensitivity to any ingredient of the test material or skin marker pen, or to latex; or any known sensitivities/allergies, including but not limited to cosmetic/toiletry products and topically applied skin treatment products/drugs.
Participant with any significant dermatological condition, such as atopic dermatitis (eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, blemishes or moles, lupus, diabetes, or connective tissue disease, that would increase the risk associated with participation. (Note: presence of non-dysplastic nevi, blemishes, or moles would be acceptable if, in the opinion of the PI, they will neither jeopardize participant safety or compromise study outcomes. A participant with dysplastic nevi should be disqualified.
Participant receiving any treatment with medications that would, in the opinion of the PI, confound study outcomes or increase the risk associated with participation, such as systemic or topical corticosteroids, antibiotics, anti-inflammatory drugs, antihistamines, antihypertension medications, or any other photosensitive medications. (Note: The prohibited medication list will be available to site staff for reference during screening)
Participant who has used topical or systemic steroids, antihistamines, antibiotics or anti-inflammatory medications within 7 days of Study Day 1 which, in the opinion of the PI, could interfere with study outcomes.

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Participant who has used/applied any personal care products (for example, lotions, sunscreens, sunless tanners) and/or topical medications in/on the test area within 24 hours of Study Day 1.
Participant who is unwilling to cease use of personal care products (for example, lotions, sunscreens, sunless tanners) and/or topical medications in/on the test area for the duration of the study.
Participant with any known communicable disease(s) (for example, Human Immunodeficiency Virus [HIV], Sexually Transmitted Diseases [STD's], Hepatitis B, Hepatitis C, and so on)
Participant with skeletal protrusions and/or extreme areas of curvature in the test area.
Participant with a medical treatment/vaccination (other than the Covid-19 vaccination) planned during the study, which would make them ineligible, place them at undue risk, or confound the outcome of the study, per the discretion of the PI.
Participant who has undergone any surgical procedure in the last 12 months.
Participant who has undergone chemical or physical treatment procedures in the test area within the last 12 months.
Planned hospitalization during the study.
Participant who exceeds a weight limit of 300 pounds due to equipment limitations.
Participant with any condition that might confound the study results, increase the risk associated with participation, or interfere with study participation.
Female participant who is pregnant, planning to become pregnant during the study, or breastfeeding (self-reported).
Participant with any visible sunburn or suntan in test area.
Participant with visible sun damage, scarring or tattoos in the test area that would interfere with study participation.
Participant with any sun exposure and/or use of an artificial tanning lamp on the test area within 2 months of Study Day 1.
Participant who is unwilling to avoid sun exposure and/or cease use of an artificial tanning lamp on the test area for the duration of the study.
Participant who has participated in any clinical study involving UV exposure within the last 2 months, or any other type of clinical study within the last 1 month.
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
Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: Clinical Evaluation of the Sun Protection Factor (SPF) of Sunscreen Products According to the FDA Final Rule: Sunscreen Drug Products (2011)

Read the detailed description

A single-center, randomized, controlled, intra-individual comparison, evaluator-blind, clinical study to determine the SPF of three sunscreen lip balms. Each participant will evaluate the three test products, an SPF standard and no treatment. Study treatments will be randomly assigned to 5 test sites delineated on the skin of the participant's back. Test sites will be exposed to doses of ultraviolet (UV) radiation and erythemal response evaluated 16-24 hours later. Minimal erythema dose (MED) will be determined for protected and unprotected sites and used to determine the SPF value of each test product.

Conditions: Sunscreening Agents
Being tested: ChapStick Lip Moisturizer Original, ChapStick Lip Moisturizer Mint, ChapStick Lip Moisturizer Black Cherry, SPF Standard Sunscreen

What participants receive

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

ChapStick Lip Moisturizer OriginalDrug
Sunscreen lip balm.
ChapStick Lip Moisturizer MintDrug
Sunscreen lip balm.
ChapStick Lip Moisturizer Black CherryDrug
Sunscreen lip balm.
SPF Standard SunscreenDrug
SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)

Study groups in NCT05085327
Study group	Role	What they receive
ChapStick Lip Moisturizer Original	Experimental	Single topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg per square centimeter [mg/cm^2]) of ChapStick Lip Moisturizer Original will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds. Receives: Drug: ChapStick Lip Moisturizer Original
ChapStick Lip Moisturizer Mint	Experimental	Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of ChapStick Lip Moisturizer Mint will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds. Receives: Drug: ChapStick Lip Moisturizer Mint
ChapStick Lip Moisturizer Black Cherry	Experimental	Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of ChapStick Lip Moisturizer Black Cherry will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds. Receives: Drug: ChapStick Lip Moisturizer Black Cherry
SPF Standard	Active comparator	Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of SPF Standard will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds. Receives: Drug: SPF Standard Sunscreen

What is being measured

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

Arithmetic Mean SPF Values
SPF values for each test product and the SPF standard were first calculated for each individual participant: SPFi = MEDp/MEDuR (p=protected [treated] site; u=unprotected [untreated] site). The arithmetic mean SPF, standard deviation (SD) and standard error (SE) were then calculated separately for each test product and the SPF standard from valid SPFi data: SPF = (∑SPFi)/n; SD = √[(∑SPFi^2) - ((∑SPFi)^2/n) / (n-1))]; SE = SD/√n (n = no. participants providing valid test results). For SPF determination to be considered valid, in compliance with FDA Final Rule 2011, the mean SPF value of the SPF standard should fall within the SD range of the expected SPF (i.e.,16.3 ± 3.43 or 12.87 to 19.73). The MED is the lowest dose of UV radiation that produces the first perceptible erythema with clearly defined borders (covering more than 50% of the exposure site), 16 to 24 hours (hrs) after UV exposure administration.
Measured: From 16 to 24 hours post UV exposure

Timeline

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

19 Oct 20214 Nov 2021

First posted20 Oct 2021
Study start19 Oct 2021
Primary completion4 Nov 2021
Study completion4 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.
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: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05085327
Sponsor's protocol ID: 218003
Status last verified: Sep 2023
First submitted: 7 Oct 2021
Last updated: 25 Mar 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.

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 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Sun Protection Factor (SPF) of Sunscreen Products According to the FDA Final Rule: Sunscreen Drug Products (2011)
ClinicalTrials.gov ID: NCT05085327
Acronym / sponsor ID: 218003
Conditions: Sunscreening Agents
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 19 Oct 2021 (actual)
Primary completion: 4 Nov 2021 (actual)
Study completion: 4 Nov 2021 (actual)
First posted: 20 Oct 2021 (actual)
Results: Posted 25 Mar 2024

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: 4

Arm	Type	Receives
ChapStick Lip Moisturizer Original	Experimental	Drug: ChapStick Lip Moisturizer OriginalSingle topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg per square centimeter [mg/cm^2]) of ChapStick Lip Moisturizer Original will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.
ChapStick Lip Moisturizer Mint	Experimental	Drug: ChapStick Lip Moisturizer MintSingle topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of ChapStick Lip Moisturizer Mint will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.
ChapStick Lip Moisturizer Black Cherry	Experimental	Drug: ChapStick Lip Moisturizer Black CherrySingle topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of ChapStick Lip Moisturizer Black Cherry will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.
SPF Standard	Active comparator	Drug: SPF Standard SunscreenSingle topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of SPF Standard will be applied to the assigned test site using a fingercot. Test material will be evenly spread over the test site using light pressure for 35 +/- 15 seconds.

Who may qualify

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

Key inclusion criteria (12 listed)

Participant must provide a signed and dated, legally effective, informed consent document, which indicates they have been informed of all pertinent aspects of the study, before any study procedures are performed.
Participant must provide relevant details of their medical history and current/recent medications and treatments (self-reported).
Participant must have completed an annual Health Insurance Portability and Accountability Act (HIPAA) Authorization form.
Participant must have completed a Photo Release Form.
Participant must be able to read, write, speak and understand English.

Key exclusion criteria (23 listed)

Participant with a scheduled or planned Covid-19 vaccination during likely dates of study participation.
Participant with a history of abnormal response to sunlight/UV radiation.
Participant with a history of sensitivity to any ingredient of the test material or skin marker pen, or to latex; or any known sensitivities/allergies, including but not limited to cosmetic/toiletry products and topically applied skin treatment products/drugs.
Participant with any significant dermatological condition, such as atopic dermatitis (eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, blemishes or moles, lupus, diabetes, or connective tissue disease, that would increase the risk associated with participation. (Note: presence of non-dysplastic nevi, blemishes, or moles would be acceptable if, in the opinion of the PI, they will neither jeopardize participant safety or compromise study outcomes. A participant with dysplastic nevi should be disqualified.
Participant receiving any treatment with medications that would, in the opinion of the PI, confound study outcomes or increase the risk associated with participation, such as systemic or topical corticosteroids, antibiotics, anti-inflammatory drugs, antihistamines, antihypertension medications, or any other photosensitive medications. (Note: The prohibited medication list will be available to site staff for reference during screening)

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 Lip Moisturizer OriginalSunscreen lip balm.	Drug	ChapStick Lip Moisturizer Original
ChapStick Lip Moisturizer MintSunscreen lip balm.	Drug	ChapStick Lip Moisturizer Mint
ChapStick Lip Moisturizer Black CherrySunscreen lip balm.	Drug	ChapStick Lip Moisturizer Black Cherry
SPF Standard SunscreenSPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)	Drug	SPF Standard

Primary outcome

Arithmetic Mean SPF Values
Time frame: From 16 to 24 hours post UV exposure
SPF values for each test product and the SPF standard were first calculated for each individual participant: SPFi = MEDp/MEDuR (p=protected [treated] site; u=unprotected [untreated] site). The arithmetic mean SPF, standard deviation (SD) and standard error (SE) were then calculated separately for each test product and the SPF standard from valid SPFi data: SPF = (∑SPFi)/n; SD = √[(∑SPFi^2) - ((∑SPFi)^2/n) / (n-1))]; SE = SD/√n (n = no. participants providing valid test results). For SPF determination to be considered valid, in compliance with FDA Final Rule 2011, the mean SPF value of the SPF standard should fall within the SD range of the expected SPF (i.e.,16.3 ± 3.43 or 12.87 to 19.73). The MED is the lowest dose of UV radiation that produces the first perceptible erythema with clearly defined borders (covering more than 50% of the exposure site), 16 to 24 hours (hrs) after UV exposure administration.

Results and safety

Results posted to the registry on 25 Mar 2024, 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	11	11

Primary outcome: Arithmetic Mean SPF Values

Time frame: From 16 to 24 hours post UV exposure. Mean (Standard Deviation). Unit: Ratio

Measure	CLM Original n = 11	SPF Standard (CLM Original Dataset) n = 11	CLM Mint n = 10	SPF Standard (CLM Mint Dataset) n = 10	CLM Black Cherry n = 11	SPF Standard (CLM Black Cherry Dataset) n = 11
Value	13.9 (1.34)	16.1 (1.16)	14.3 (1.25)	15.8 (0.79)	14.8 (2.74)	16.1 (1.16)

CLM Original: CLM Original: Labeled SPF: 13
CLM Mint: CLM Mint: Labeled SPF: 13
CLM Black Cherry: CLM Black Cherry: Labeled SPF: 13

Population analysed: Analysis Population: all randomized participants who received study treatment and provided valid results.

Adverse events

Time frame: From screening until 14 days after last dose administration of trial product (Up to 16 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CLM Original	0 of 11 (0%)	0 of 11 (0%)	0 of 11
SPF Standard (CLM Original Dataset)	0 of 11 (0%)	0 of 11 (0%)	0 of 11
CLM Mint	0 of 10 (0%)	0 of 10 (0%)	0 of 10
SPF Standard (CLM Mint Dataset)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
CLM Black Cherry	0 of 11 (0%)	0 of 11 (0%)	0 of 11
SPF Standard (CLM Black Cherry Dataset)	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 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

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 12 inclusion and 23 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 25 Mar 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 25 Mar 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?

Arithmetic Mean SPF Values (time frame: From 16 to 24 hours post UV 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 NCT05085327.

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 25 Mar 2024.