Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm

NCT05082376 | Completed Results

• 1 other identifier: 218004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Pre-treatment), 2, 4, 6 and 8 hours post-treatment

Secondary Outcomes (1)

• Percentage of Participants With Improved Corneometer Measurement

  2, 4, 6 and 8 hours post-treatment

Study Arms (2)

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.

Drug: CLM Original

Control Arm

NO INTERVENTION

No treatment will be applied to the assigned control site.

Interventions

CLM Original DRUG

Sunscreen lip balm.

Test Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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 skin cancer, or currently undergoing treatment for active cancer of any kind
• Participant with diabetes
• 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

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

GSK Investigational Site

Piscataway, New Jersey, 08854, United States

Location

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+44 7880 182593

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: November 1, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoint and safety data of the study.
• Access Criteria: 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.

Locations

US (1)