Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema

Study Overview
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Brief Summary
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The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

Detailed Description
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Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control). Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas. Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.

Official Title
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A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: EpiCeram Skin Barrier Emulsion
* Drug: Experimental Product 1% Colloidal Oatmeal Balm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) Male or female of any race or ethnicity, ages 12 and older Diagnosed as having eczema Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study Exclusion Criteria: Known sensitivity to any investigational product ingredient Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study Individuals with a history of skin cancer Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema Participation in any clinical study within 30 days of Visit 1 Active infection of any type at the start of the study Diagnosed as having severe eczema Has a compromised immune system Individuals with any planned surgeries and/or invasive medical procedures during the course of the study Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Ages Eligible for Study
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Minimum Age: 12 Years

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive Control<br>Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. | Device: EpiCeram Skin Barrier Emulsion<br>* EpiCeram Skin Barrier Emulsion<br>|
| Experimental: Experimental<br>Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed. | Drug: Experimental Product 1% Colloidal Oatmeal Balm<br>* Experimental Product 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 |
| --- | --- | --- |
| Change From Baseline in the Itch Assessment Score Immediately Following Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to immediately following treatment | 
| Change From Baseline in the Itch Assessment Score 1 Hour After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to one hour after treatment | 
| Change From Baseline in the Itch Assessment Score 2 Hours After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to two hours after treatment | 
| Change From Baseline in the Itch Assessment Score 3 Hours After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to three hours after treatment | 
| Change From Baseline in the Itch Assessment Score 4 Hours After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to four hours after treatment | 
| Change From Baseline in the Itch Assessment Score 5 Hours After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to five hours after treatment | 
| Change From Baseline in the Itch Assessment Score 6 Hours After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to six hours after treatment | 
| Change From Baseline in the Itch Assessment Score 7 Days After Treatment | The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable. | Baseline to seven days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to Immediately following treatment | 
| Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to one hour after treatment | 
| Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to two hours after treatment | 
| Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to three hours after treatment | 
| Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to four hours after treatment | 
| Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to five hours after treatment | 
| Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to six hours after treatment | 
| Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment | Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. | Baseline to seven days after treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin | Questions were answered before treatment by the participant. The question is I'm less distracted by my itchy skin | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin | Questions were answered before treatment by the participant. The question is I wake up to calmer skin | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin | Questions were answered before treatment by the participant. The question is My skin feels smooth | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin | Questions were answered before treatment by the participant. The question is I feel comfortable showing my skin | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin | Questions were answered before treatment by the participant. The question is My skin feels moisturized | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin | Questions were answered before treatment by the participant. The question is My skin feels touchable | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Soft Skin | Questions were answered before treatment by the participant. The question is My skin feels soft | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days | Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days | Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, how would you describe your skin upon awakening? | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days | Questions were answered before treatment by the participant. The question is Thinking about how well you slept during the past two days, would you say your sleep was? | 0 Days - Pre-treatment | 
| Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days | Questions were answered before treatment by the participant. The question is Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were | 0 Days - Pre-treatment | 
| Participant Questionnaire Immediately After Treatment - Product Fast Absorbing | Questions were answered immediately after treatment by the participant. The question is This product is fast absorbing | 0 Days - Immediately after treatment | 
| Participant Questionnaire Immediately After Treatment - Calm Skin | Questions were answered immediately after treatment by the participant. The question is This product calms my skin | 0 Days - Immediately after treatment | 
| Participant Questionnaire Immediately After Treatment - Moisturized Skin | Questions were answered immediately after treatment by the participant. The question is This product leaves my skin feeling immediately moisturized | 0 Days - Immediately after treatment | 
| Participant Questionnaire Immediately After Treatment - Product Does Not Sting | Questions were answered immediately after treatment by the participant. The question is This product does not sting when applied | 0 Days - Immediately after treatment | 
| Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture | Questions were answered four hours after treatment by the participant. The question is This product provides long lasting moisture | Four hours after treatment | 
| Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft | Questions were answered four hours after treatment by the participant. The question is This product leaves my skin feeling soft | Four hours after treatment | 
| Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture | Questions were answered five hours after treatment by the participant. The question is This product provides long lasting moisture | Five hours after treatment | 
| Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft | Questions were answered five hours after treatment by the participant. The question is This product leaves my skin feeling soft | Five hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture | Questions were answered six hours after treatment by the participant. The question is This product provides long lasting moisture | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Calms Skin | Questions were answered six hours after treatment by the participant. The question is This product calms my skin | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin | Questions were answered six hours after treatment by the participant. The question is I'm less distracted by my itchy skin | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin | Questions were answered six hours after treatment by the participant. The question is I feel comfortable showing my skin | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Shield for Skin | Questions were answered six hours after treatment by the participant. The question is This product feels like a shield for my skin | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized | Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling moisturized | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable | Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel touchable | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft | Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel soft | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth | Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling smooth | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin | Questions were answered six hours after treatment by the participant. The question is Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were | Six hours after treatment | 
| Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin | Questions were answered six hours after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin after using this product, would you say that you were | Six hours after treatment | 
| Participant Questionnaire 7 Days After Treatment - Skin Feels Calm | Questions were answered seven days after treatment by the participant. The question is This product calms my skin | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin | Questions were answered seven days after treatment by the participant. The question is I'm less distracted by my itchy skin | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking | Questions were answered seven days after treatment by the participant. The question is I wake up to calmer skin | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin | Questions were answered seven days after treatment by the participant. The question is I feel comfortable showing my skin | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture | Questions were answered seven days after treatment by the participant. The question is This product provides long lasting moisture to my skin | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Shield for Skin | Questions were answered seven days after treatment by the participant. The question is This product feels like a shield for my skin | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized | Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable | Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel touchable | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets | Questions were answered seven days after treatment by the participant. The question is This product does not rub off on sheets | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Skin Feels Soft | Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel soft | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Moisturized All Day | Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized all day | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Slept Better | Questions were answered seven days after treatment by the participant. The question is I slept better due to less itching or skin discomfort | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth | Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling smooth | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin | Questions were answered seven days after treatment by the participant. The question is Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Skin on Waking | Questions were answered seven days after treatment by the participant. The question is Thinking about your experience when using this product, how would you describe your skin upon awakening? | Seven days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Degree of Sleep | Questions were answered seven days after treatment by the participant. The question is Thinking about how well you slept when using this product, would you say your sleep was? | 7 days after treatment | 
| Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin | Questions were answered seven days after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin while using this product, would you say that you were | Seven days after treatment | 

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