Title
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
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.
Phase
Phase 2Lead Sponsor
Johnson and JohnsonStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Atopic DermatitisStudy Participants
53The 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.
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.
EpiCeram Skin Barrier Emulsion
Experimental Product 1% Colloidal Oatmeal Balm
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.
Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.
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
| Event Type | Organ System | Event Term | 1% Colloidal Oatmeal Balm | EpiCeram Skin Barrier Emulsion |
|---|
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Questions were answered before treatment by the participant. The question is "My skin feels smooth"
Questions were answered before treatment by the participant. The question is "I'm less distracted by my itchy skin"
Questions were answered before treatment by the participant. The question is "I wake up to calmer skin"
Questions were answered before treatment by the participant. The question is "I feel comfortable showing my skin"
Questions were answered before treatment by the participant. The question is "My skin feels moisturized"
Questions were answered before treatment by the participant. The question is "My skin feels touchable"
Questions were answered before treatment by the participant. The question is "My skin feels soft"
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"
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?"
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?"
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"
Questions were answered immediately after treatment by the participant. The question is "This product is fast absorbing"
Questions were answered immediately after treatment by the participant. The question is "This product calms my skin"
Questions were answered immediately after treatment by the participant. The question is "This product leaves my skin feeling immediately moisturized"
Questions were answered immediately after treatment by the participant. The question is "This product does not sting when applied"
Questions were answered six hours after treatment by the participant. The question is "This product feels like a shield for my skin"
Questions were answered four hours after treatment by the participant. The question is "This product provides long lasting moisture"
Questions were answered four hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Questions were answered five hours after treatment by the participant. The question is "This product provides long lasting moisture"
Questions were answered five hours after treatment by the participant. The question is "This product leaves my skin feeling soft"
Questions were answered six hours after treatment by the participant. The question is "This product provides long lasting moisture"
Questions were answered six hours after treatment by the participant. The question is "This product calms my skin"
Questions were answered six hours after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Questions were answered six hours after treatment by the participant. The question is "I feel comfortable showing my skin"
Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel touchable"
Questions were answered six hours after treatment by the participant. The question is "This product makes my skin feel soft"
Questions were answered six hours after treatment by the participant. The question is "This product leaves my skin feeling smooth"
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"
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"
Questions were answered seven days after treatment by the participant. The question is "This product calms my skin"
Questions were answered seven days after treatment by the participant. The question is "I'm less distracted by my itchy skin"
Questions were answered seven days after treatment by the participant. The question is "I wake up to calmer skin"
Questions were answered seven days after treatment by the participant. The question is "I feel comfortable showing my skin"
Questions were answered seven days after treatment by the participant. The question is "This product provides long lasting moisture to my skin"
Questions were answered seven days after treatment by the participant. The question is "This product feels like a shield for my skin"
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized"
Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel touchable"
Questions were answered seven days after treatment by the participant. The question is "This product does not rub off on sheets"
Questions were answered seven days after treatment by the participant. The question is "This product makes my skin feel soft"
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling moisturized all day"
Questions were answered seven days after treatment by the participant. The question is "I slept better due to less itching or skin discomfort"
Questions were answered seven days after treatment by the participant. The question is "This product leaves my skin feeling smooth"
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"
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?"
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?"
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"
