Eligibility |
Inclusion Criteria:
- 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)
- 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)
Exclusion Criteria:
- 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
- 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
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