Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the static SPF of three sunscreen products (ChapStick Active Performance [CAP] UnScented, CAP Herbal Mint and CAP Mountain Berry) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAP UnScented | Experimental | Single topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg per square centimeter [mg/cm^2]) of CAP UnScented 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. |
|
| CAP Herbal Mint | Experimental | Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of CAP Herbal 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. |
|
| CAP Mountain Berry | Experimental | Single topical application: 80 +/- 2 mg (2.0 +/- 0.05 mg/cm^2) of CAP Mountain Berry 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAP UnScented | Drug | Sunscreen lip balm. |
| |
| CAP Herbal Mint |
| Measure | Description | Time Frame |
|---|---|---|
| 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 = (ΣSPFi)/n; SD = √[(ΣSPFi^2) - ((ΣSPFi)^2/n) /(n-1))]; SE = SD/√n (n = number 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. | From 16 to 24 hours post UV exposure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Winston-Salem | North Carolina | 27101 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoint and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Not provided
Study participants were randomly assigned to receive a single topical application of each 4 study treatments (ChapStick Active Performance [CAP] UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site used to determine repeat unprotected Minimal Erythema Dose [MEDuR].
The study was conducted at single center in United States.
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Study participants were randomly assigned to receive a single topical application of each 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site. Each product/untreated test site was delineated on a site on the participants back. Around 80 +/- 2 milligrams (mg) product was applied to each 40 square centimeter (cm^2) test site (2.00 +/- 0.05 mg/cm^2). Test sites received a progressive sequence of timed ultraviolet (UV) radiation exposures and were evaluated for erythema immediately after irradiation and 16-24 hours later. A total of 13 participants were enrolled; 11 received CAP UnScented (11 test sites, of which 1 became invalid); 11 received CAP Herbal Mint (11 test sites, of which 1 became invalid); 13 received CAP Mountain Berry (13 test sites, of which 2 became invalid); 13 received SPF Standard (13 test sites); and 13 participants with 13 untreated test sites (of which 1 became invalid). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population: all randomized participants who received at least one dose of a study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Study participants were randomly assigned to receive a single topical application of each 4 study treatments (CAP UnScented; CAP Herbal Mint; CAP Mountain Berry and SPF Standard) + 1 untreated site. Each product/untreated test site was delineated on a site on the participants back. Around 80 +/- 2 mg product was applied to each 40 cm^2 test site (2.00 +/- 0.05 mg/cm^2). Test sites received a progressive sequence of timed UV radiation exposures and were evaluated for erythema immediately after irradiation and 16-24 hours later. A total of 13 participants were enrolled; 11 received CAP UnScented (11 test sites, of which 1 became invalid); 11 received CAP Herbal Mint (11 test sites, of which 1 became invalid); 13 received CAP Mountain Berry (13 test sites, of which 2 became invalid); 13 received SPF Standard (13 test sites); and 13 participants with 13 untreated test sites (of which 1 became invalid). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 = (ΣSPFi)/n; SD = √[(ΣSPFi^2) - ((ΣSPFi)^2/n) /(n-1))]; SE = SD/√n (n = number 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. | Analysis Population: all randomized participants who received study treatment and provided valid results. Only those participants who have valid sites were analyzed. | Posted | Mean | Standard Deviation | Ratio | From 16 to 24 hours post UV exposure | test sites on back | test sites on back |
From screening until 14 days after last dose administration of trial product (Up to 16 days)
AEs, and therefore all serious adverse events (SAEs), were to be collected from immediately after a participant provided written consent to participate in the trial until 14 days after the last administration of study treatment (or the last study procedure). All SAEs were to be reported within 24 hours of detection. Localized erythema caused by exposure of the skin to UV radiation is expected and was not reported as an adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAP UnScented | All participants with valid data for CAP UnScented. | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +44 7880 182593 | ww.clinical-trial-register@haleon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2021 | Nov 10, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Only the outcomes (erythema) assessor is blinded to treatment allocation
| Drug |
Sunscreen lip balm. |
|
| CAP Mountain Berry | Drug | Sunscreen lip balm. |
|
| SPF Standard Sunscreen | Drug | SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone) |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | CAP UnScented | All participants with valid data for CAP UnScented. |
| OG001 | SPF Standard (CAP UnScented Dataset) | All participants with valid data for SPF Standard (CAP UnScented dataset). |
| OG002 | CAP Herbal Mint | All participants with valid data for CAP Herbal Mint. |
| OG003 | SPF Standard (CAP Herbal Mint Dataset) | All participants with valid data for SPF Standard (CAP Herbal Mint dataset). |
| OG004 | CAP Mountain Berry | All participants with valid data for CAP Mountain Berry. |
| OG005 | SPF Standard (CAP Mountain Berry Dataset) | All participants with valid data for SPF Standard (CAP Mountain Berry dataset). |
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | SPF Standard (CAP UnScented Dataset) | All participants with valid data for SPF Standard (CAP UnScented dataset). | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | CAP Herbal Mint | All participants with valid data for CAP Herbal Mint. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | SPF Standard (CAP Herbal Mint Dataset) | All participants with valid data for SPF Standard (CAP Herbal Mint dataset). | 0 | 11 | 0 | 11 | 0 | 11 |
| EG004 | CAP Mountain Berry | All participants with valid data for CAP Mountain Berry. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG005 | SPF Standard (CAP Mountain Berry Dataset) | All participants with valid data for SPF Standard (CAP Mountain Berry dataset). | 0 | 13 | 0 | 13 | 0 | 13 |
HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.