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

Johnson & Johnson Consumer Inc. (J&JCI)53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

EpiCeram Skin Barrier EmulsionDEVICE

EpiCeram Skin Barrier Emulsion

Experimental Product 1% Colloidal Oatmeal BalmDRUG

Experimental Product 1% Colloidal Oatmeal Balm

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) 2. Male or female of any race or ethnicity, ages 12 and older 3. Diagnosed as having eczema 4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study Exclusion Criteria: 1. Known sensitivity to any investigational product ingredient 2. Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study 3. Individuals with a history of skin cancer 4. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema 5. Participation in any clinical study within 30 days of Visit 1 6. Active infection of any type at the start of the study 7. Diagnosed as having severe eczema 8. Has a compromised immune system 9. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study 10. Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Locations (2)

Stephens & Associates (Colorado Research Center)

Colorado Springs, Colorado, United States

Stephens & Associates (Texas Reserach Center)

Richardson, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to five hours after treatment

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: Baseline to Immediately following treatment

Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment

Time frame: Baseline to one hour after treatment

Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment

Time frame: Baseline to two hours after treatment

Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment

Time frame: Baseline to three hours after treatment

Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment

Time frame: Baseline to four hours after treatment

Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment

Time frame: Baseline to five hours after treatment

Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment

Time frame: Baseline to six hours after treatment

Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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?"

Time frame: 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?"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"