Clinical trial: A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer (NCT03719742)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 7 Years

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Entailment