A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer

This single-center clinical trial is being conducted to demonstrate that the Sponsor's
product does not statistically or clinically worsen eczema scores in children aged 6 months
through 7 years after 4 weeks of treatment compared to baseline scores.

Safety and efficacy will be assessed through clinical grading at baseline and week 4.
Efficacy will also be assessed through Corneometer and Tewameter measurements at baseline and
week 4. Microbiome skin swab sampling will be performed at baseline and week 4.
Parents/guardians will complete Patient Oriented Eczema Measure and Family Dermatology
Quality of Life Index at baseline and week 4.

Inclusion Criteria:

1. Healthy, female or male infants/children, aged 6 months through 7 years.

2. In generally good health (physical, mental, and social well-being, not merely the
absence of disease/infirmity), according to parent/legal guardian report.

3. Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type).

4. Having mild to moderate eczema involving 3% to 20% of body surface area, and with EASI
score in the range of 1.1 to 20.0, further stratified into the following subgroups:

- Approximately 60% of subjects with clinically determined EASI score of 1.1-7.0
(mild)

- Approximately 40% of subjects with clinically determined EASI score of 7.1 to
20.0 (moderate)

5. Having a parent/legal guardian at least 18 years of age who regularly bathes the child
and otherwise cares for the child, and who presents proof of guardianship (eg,
insurance card, certificate of residence, or copy of officially issued family
registration) at the baseline visit.

6. Having a parent/legal guardian willing to provide written informed consent and who can
read, speak, write, and understand English.

7. Whose parent/legal guardian is willing to sign a photography release.

8. Willing, and having a parent/legal guardian who is willing, to cooperate and
participate by following study requirements (including those outlined in section 7.3)
for the duration of the study and to report any changes in health status or
medications, AE symptoms, or reactions immediately.

9. Willing to bring in currently used moisturizer and cleanser to visit 1 for
documentation by clinic staff.

Exclusion Criteria:

1. Diagnosed with known allergies to skin care products or ingredient(s) in the test
product.

2. History of skin cancer within the past 5 years.

3. Individuals who have clinically active bacterial, fungal, or viral skin infections or
those who have a history of recurrent cutaneous infections, according to subject
self-report.

4. Individuals whose use of topical corticosteroids or systemic medications for their
eczema has not been stable for at least 6 weeks prior to study start. This includes
medicines such as hydrocortisone, clobetasol, betamethasone, halobetasol, fluocinide,
diflorasone, mometasone, halcinonide, desoximetasone, pimecrolimus, tacrolimus,
crisabarole, and fluticasone.

5. Having a health condition and/or pre-existing or dormant dermatologic disease on the
body (eg, psoriasis, rosacea, acne [severe acne, acne conglobata, nodules, or cysts],
seborrheic dermatitis, severe excoriations.) that the Investigator or designee deems
inappropriate for participation or could interfere with the outcome of the study.

6. Who have observable suntan, scars, nevi, excessive hair, tattoos, or other dermal
conditions on the body that might influence the test results in the opinion of the
Investigator or designee.

7. Having a history of immunosuppression/immune deficiency disorders (including HIV
infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), had an
organ transplant (heart, kidney, etc), or currently using oral or systemic
immunosuppressive medications and biologics that are not used for the treatment of
eczema (eg, azathioprine, belimumab, Cimzia, Cosentyx, cyclophosphamide, cyclosporine,
Enbrel, Humira, Imuran, Kineret, mycophenolate mofetil, methotrexate, Orencia,
Remicade, Rituxan, Siliq, Simponi, Stelara, Taltz) and/or undergoing radiation or
chemotherapy as determined by study documentation.

8. Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or
hypothyroidism that is not controlled by diet or medication; experiencing asthma
flares or having multiple health conditions.

9. Having started a long-term medication within the last 2 months.

10. With any planned surgeries and/or invasive medical procedures during the course of the
study. Non-invasive planned surgeries will be reviewed for their impact on the study
outcome and acceptability by the Investigator or designee.

11. Who are currently participating in any other clinical trial at Stephens, another
research facility, or doctor's office

12. Who have participated in any clinical trial or experimental treatment involving the
test area within 4 weeks prior to inclusion into the study at Stephens, at another
research facility or doctor's office.

13. Infants/children with a history of or exhibiting signs and symptoms of any systemic
disease that may interfere with study evaluations (eg, urinary tract infections,
significant bowel or urinary congenital malformation).

14. Infant/child who has had a recent change in her/his dietary intake or who has had
severe diaper rash within 1 week prior to baseline.

15. Individuals who have received PUVA therapy for atopic dermatitis within 4 weeks prior
to inclusion in the study.

16. Individuals who have received phototherapy within 2 weeks prior to inclusion in the
study.

17. Individuals who have changed the type of moisturizer or cleanser used within the last
6 weeks prior to inclusion in the study.