Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

Study Overview
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Brief Summary
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The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Detailed Description
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At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Official Title
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Clinical Trial to Evaluate the Tolerance of a Nighttime Moisturizing Balm on Babies and Adults With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis (AD)

Intervention / Treatment
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* Drug: Experimental Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above. Adult subjects only - Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months. Diagnosed as having Eczema. Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study. Willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study. Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing. Willing to not enter/use hot tub or whirlpool bath for the duration of the study. Willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary. Exclusion Criteria: Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema. Adults Females who are pregnant (self-reported) or breastfeeding. Participation in any clinical study within 30 days of Visit 1. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids. Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections. Subjects who are currently on phototherapy.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult Tolerance Assessment<br>Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin | Drug: Experimental Product<br>* 1% Colloidal Oatmeal Balm<br>* Other names: Eczema Moisturizing Balm;|
| Experimental: Baby (infants, toddlers, young children) Tolerance Assessment<br>Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin | Drug: Experimental Product<br>* 1% Colloidal Oatmeal Balm<br>* Other names: Eczema Moisturizing Balm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage With Erythema on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the face at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Erythema on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the arms at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Erythema on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the legs at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Erythema on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with erythema on the torso at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Erythema on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the face at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Erythema on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the arms at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Erythema on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the legs at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Erythema on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with erythema on the torso at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Erythema on the Face at Day 1 | Percentage of adults and babies with erythema on the face at Day 1 | At Day 1 | 
| Percentage With Erythema on the Arms at Day 1 | Percentage of adults and babies with erythema on the arms at Day 1 | At Day 1 | 
| Percentage With Erythema on the Legs at Day 1 | Percentage of adults and babies with erythema on the legs at Day 1 | At Day 1 | 
| Percentage With Erythema on the Torso at Day 1 | Percentage of adults and babies with erythema on the torso at Day 1 | At Day 1 | 
| Percentage With Erythema on the Face at Day 7 | Percentage of adults and babies with erythema on the face at Day 7 | At Day 7 | 
| Percentage With Erythema on the Arms at Day 7 | Percentage of adults and babies with erythema on the arms at Day 7 | At Day 7 | 
| Percentage With Erythema on the Legs at Day 7 | Percentage of adults and babies with erythema on the legs at Day 7 | At Day 7 | 
| Percentage With Erythema on the Torso at Day 7 | Percentage of adults and babies with erythema on the torso at Day 7 | At Day 7 | 
| Percentage With Erythema on the Face at Day 14 | Percentage of adults and babies with erythema on the face at Day 14 | At Day 14 | 
| Percentage With Erythema on the Arms at Day 14 | Percentage of adults and babies with erythema on the arms at Day 14 | At Day 14 | 
| Percentage With Erythema on the Legs at Day 14 | Percentage of adults and babies with erythema on the legs at Day 14 | At Day 14 | 
| Percentage With Erythema on the Torso at Day 14 | Percentage of adults and babies with erythema on the torso at Day 14 | At Day 14 | 
| Percentage With Edema on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the face at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Edema on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the arms at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Edema on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the legs at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Edema on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with edema on the torso at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Edema on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the face at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Edema on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the arms at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Edema on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the legs at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Edema on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with edema on the torso at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Edema on the Face at Day 1 | Percentage of adults and babies with edema on the face at Day 1 | At Day 1 | 
| Percentage With Edema on the Arms at Day 1 | Percentage of adults and babies with edema on the arms at Day 1 | At Day 1 | 
| Percentage With Edema on the Legs at Day 1 | Percentage of adults and babies with edema on the legs at Day 1 | At Day 1 | 
| Percentage With Edema on the Torso at Day 1 | Percentage of adults and babies with edema on the torso at Day 1 | At Day 1 | 
| Percentage With Edema on the Face at Day 7 | Percentage of adults and babies with edema on the face at Day 7 | At Day 7 | 
| Percentage With Edema on the Arms at Day 7 | Percentage of adults and babies with edema on the arms at Day 7 | At Day 7 | 
| Percentage With Edema on the Legs at Day 7 | Percentage of adults and babies with edema on the legs at Day 7 | At Day 7 | 
| Percentage With Edema on the Torso at Day 7 | Percentage of adults and babies with edema on the torso at Day 7 | At Day 7 | 
| Percentage With Edema on the Face at Day 14 | Percentage of adults and babies with edema on the face at Day 14 | At Day 14 | 
| Percentage With Edema on the Arms at Day 14 | Percentage of adults and babies with edema on the arms at Day 14 | At Day 14 | 
| Percentage With Edema on the Legs at Day 14 | Percentage of adults and babies with edema on the legs at Day 14 | At Day 14 | 
| Percentage With Edema on the Torso at Day 14 | Percentage of adults and babies with edema on the torso at Day 14 | At Day 14 | 
| Percentage With Scaling on the Face at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the face at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Scaling on the Arms at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the arms at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Scaling on the Legs at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the legs at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Scaling on the Torso at Baseline Before Investigational Product Application | Percentage of adults and babies with scaling on the torso at baseline before investigational product application | At baseline before investigational product application | 
| Percentage With Scaling on the Face at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the face at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Scaling on the Arms at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the arms at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Scaling on the Legs at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the legs at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Scaling on the Torso at Baseline After Investigational Product Application | Percentage of adults and babies with scaling on the torso at baseline after investigational product application | At baseline after investigational product application | 
| Percentage With Scaling on the Face at Day 1 | Percentage of adults and babies with scaling on the face at Day 1 | At Day 1 | 
| Percentage With Scaling on the Arms at Day 1 | Percentage of adults and babies with scaling on the arms at Day 1 | At Day 1 | 
| Percentage With Scaling on the Legs at Day 1 | Percentage of adults and babies with scaling on the legs at Day 1 | At Day 1 | 
| Percentage With Scaling on the Torso at Day 1 | Percentage of adults and babies with scaling on the torso at Day 1 | At Day 1 | 
| Percentage With Scaling on the Face at Day 7 | Percentage of adults and babies with scaling on the face at Day 7 | At Day 7 | 
| Percentage With Scaling on the Arms at Day 7 | Percentage of adults and babies with scaling on the arms at Day 7 | At Day 7 | 
| Percentage With Scaling on the Legs at Day 7 | Percentage of adults and babies with scaling on the legs at Day 7 | At Day 7 | 
| Percentage With Scaling on the Torso at Day 7 | Percentage of adults and babies with scaling on the torso at Day 7 | At Day 7 | 
| Percentage With Scaling on the Face at Day 14 | Percentage of adults and babies with scaling on the face at Day 14 | At Day 14 | 
| Percentage With Scaling on the Arms at Day 14 | Percentage of adults and babies with scaling on the arms at Day 14 | At Day 14 | 
| Percentage With Scaling on the Legs at Day 14 | Percentage of adults and babies with scaling on the legs at Day 14 | At Day 14 | 
| Percentage With Scaling on the Torso at Day 14 | Percentage of adults and babies with scaling on the torso at Day 14 | At Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Skin Irritation