A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability (assessed by clinical grading and parent-perception) of the investigational cream when used in conjunction with a baby wash in babies, toddlers, and children with mild to moderate atopic dermatitis.

Official Title
-----------------
A Clinical Evaluation of the Safety and Efficacy of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Other: Wash IP
* Other: Cream IP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Child Fitzpatrick skin type I to VI Child must have at least 1 target lesion based on the atopic dermatitis severity index (ADSI) with a score of 2-12 and an erythema sub score of at least 2 (moderate) Has mild to moderate atopic dermatitis (as per Rajka-Langeland Severity Index; graded as 3.0 to 7.5 inclusive) Child must have parent-assessed history of itch Has parent-perceived sensitive skin For Parents Willing to undergo a 3-day washout period prior to the baseline assessments. During this run-in period, parents will be asked to refrain from using prescription and over-the-counter (OTC) eczema treatments on their child; Acute rescue treatment will be permitted (type of rescue treatment will be determined by principal investigator [PI]) Has signed the informed consent document (ICD), including Health Insurance Portability and Accountability Act (HIPAA) disclosure Exclusion Criteria: Has known allergies or adverse reactions to common topical skincare products or ingredients of the investigational products (IPs) Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to Visit 1 For Child Presents with a skin condition that may influence the outcome of the study (specifically psoriasis or active skin cancer) Severe atopic dermatitis (AD) as determined by the Rajka-Langeland Severity Index For Parent Is self-reported to be pregnant or planning to become pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 72 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wash and Cream Investigational Product (IP)<br>Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks. Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks. | Other: Wash IP<br>* Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks.<br>Other: Cream IP<br>* Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use | EASI is a composite scoring system index which is used to measure the severity of 4 clinical manifestations of atopic dermatitis (erythema, edema/induration/papulation, excoriations, and lichenification) according to the percentage of affected area in each of the 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Final scores range from 0 (no disease anywhere on the body) to 72 (severest disease on all body areas). | Baseline, Week 4 | 
| Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use | ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion). | Baseline, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Skin Microbiome | Change from baseline in skin microbiome in lesion versus adjacent non-lesional site will be assessed. Microbiome samples collected from the identified lesional site and an adjacent non-lesional site by swabbing technique will be analyzed by using 16s ribonucleic acid (RNA) sequencing. | Baseline, Day 1, 3, 7 and Week 4 | 
| Change From Baseline in EASI | EASI is a composite scoring system index which is used to measure the severity of 4 clinical manifestations of atopic dermatitis (erythema, edema/induration/papulation, excoriations, and lichenification) according to the percentage of affected area in each of the 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Final scores range from 0 (no disease anywhere on the body) to 72 (severest disease on all body areas). | Baseline, Day 1, 3 and 7 | 
| Change From Baseline in ADSI | ADSI is a scoring system that reflects the severity of a target eczema lesion. The ADSI score is a sum of scores for 5 different parameters - erythema, itching, exudation, excoriation, lichenification - which are each measured on a scale of 0 (none) to 3 (severe). The total score can range from 0 (no eczema signs) to 15 (severe eczema lesion). | Baseline, Day 1, 3 and 7 | 
| Change From Baseline in Caregiver Itch Assessment Score | Parent participant will assess how much itching/scratching the child participant has been exhibiting on a scale of 1 (none) to 4 (all the time). An option of I don't have an opinion will be included. | Baseline, Day 1, 3, 7 and Week 4 | 
| Change From Baseline in Infant Dermatitis Quality of Life Index (IDQoL) | IDQoL is a validated questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life in infants aged 0-3 years. The Infant's Dermatitis Quality of Life Index is calculated by summing the score of each question: for question 1 (0 [none] to 3 [all the time]), For question 2 (0 [happy] to 3 [always crying]), For question 3 (0 [0-15 minutes to 3 [More than 2 hours]), For question 4 (0 [less than one hour] to 3 [Five hours or more]), and For questions 5 to 10 (0 [None] to 3 [Very much]), resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The severity of eczema is scored separately and can be correlated with the Infants' Dermatitis Quality of Life Index. The score of Dermatitis severity ranges from 0 (None) to 4 (Extremely severe). | Baseline, Day 1, 3, 7 and Week 4 | 
| Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score | BISQ-R is an age-based, norm-referenced scoring system that provides a comprehensive assessment of infant and toddler sleep patterns. Five (5) items related to sleep onset latency, number, and duration of night wakings, longest stretch of sleep and total night sleep. Parent perception consists of 3 items related to bedtime difficulty, overnight sleep, and overall child sleep problems. Parent behaviors consisting of 11 items related to bedtime routine consistency, bedtime, parental behavior at time of sleep onset and night wakings, sleep locations at time of sleep onset and following night wakings that may impact sleep outcomes. Score ranging from 0-100 is derived for each sub-scale, with higher scores denoting better sleep quality, more positive perceptions of sleep quality, and parental habits that promote healthy sleep behaviors and independent infant sleep, respectively. Total score is calculated as an average of infant sleep, parent perceptions and parent behavior subscale scores. | Baseline, Day 1, 3, 7 and Week 4 | 
| Parent Perceived Product Efficacy as Assessed by Parental Questionnaire | Parent perceived product efficacy will be assessed by using parental questionnaire. Participant responses for each question will have 5 response options, the following numerical assignment could be one of the following choices: (1) Strongly Disagree, (2) Disagree Somewhat, (3) Neither Disagree or Agree, (4) Agree Somewhat, (5) Strongly Agree. | Baseline (immediately after first use) and Week 4 | 
| Change From Baseline in Transepidermal Water Loss (TEWL) Measurement in Lesion and Adjacent Non-lesional Site | Change from Baseline in TEWL measurement on both the identified lesional site and an adjacent or non-lesional site will be reported. The DermaLab TEWL instrument uses a non-invasive probe, which measures the passive transfer of water through the stratum corneum. | Baseline, Day 1, 3, 7 and Week 4 | 
| TEWL Measurement Difference Between Lesion and Adjacent Non-lesional Site | TEWL measurement difference between lesional site and an adjacent non-lesional site will be reported. The DermaLab TEWL instrument uses a non-invasive probe, which measures the passive transfer of water through the stratum corneum. | Day 1, 3, 7 and Week 4 | 
| Change from Baseline in Skin Hydration in Lesion and Adjacent Non-lesional Site | Change from Baseline in skin hydration on both the identified lesional site and an adjacent or non-lesional site will be reported. The DermaLab hydration instrument uses a non-invasive probe, which measures the water content of the stratum corneum. | Baseline, Day 1, 3, 7 and Week 4 | 
| Skin Hydration Difference between Lesion and Adjacent Non-lesional Site | Skin hydration difference between lesion and adjacent non-lesional site will be reported. The DermaLab hydration instrument uses a non-invasive probe, which measures the water content of the stratum corneum. | Day 1, 3, 7 and Week 4 | 
| Change From Baseline in Skin pH in Lesion Versus Adjacent Non-lesional Site | Change from Baseline in skin pH on both the identified lesional site and an adjacent or non-lesional site will be reported. The DermaLab skin pH instrument uses a non-invasive probe, which measures the pH of the stratum corneum. | Baseline, Day 1, 3, 7 and Week 4 | 
| Skin pH Difference between Lesion and Adjacent Non-lesional Site | Skin pH difference between lesion and adjacent non-lesional site will be reported. The DermaLab skin pH instrument uses a non-invasive probe, which measures the pH of the stratum corneum. | Day 1, 3, 7 and Week 4 |