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.

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Device: EpiCeram Skin Barrier Emulsion; Drug: Experimental Product 1% Colloidal Oatmeal Balm

Detailed Description

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
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
      • Stephens & Associates (Colorado Research Center)
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens & Associates (Texas Reserach Center)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive Control; 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; EpiCeram Skin Barrier Emulsion
Experimental: Experimental; Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.	Drug: Experimental Product 1% Colloidal Oatmeal Balm; Experimental Product 1% Colloidal Oatmeal Balm; Other Names: Eczema Moisturizing Balm

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Study Director: Amisha Parikh-Das, PhD, Johnson & Johnson Consumer Inc. (J&JCI); Principal Investigator: Lily Jiang, PhD, Stephens & Associates, Inc (Texas Research Center); Principal Investigator: Kun M Qian, MD, Stephens & Associates, Inc (Colorado Research Center)

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Eczema, Itchy Skin
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic; Anti-Infective Agents; Antifungal Agents; Decanoic acid
• Other Study ID Numbers: CO - 151102105611 - SACT