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

Atopic Dermatitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691507
• Other study ID #: CO - 151102105611 - SACT
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2016
• Last updated: October 3, 2016
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Pruritus

Intervention

Device:
• EpiCeram Skin Barrier Emulsion
EpiCeram Skin Barrier Emulsion

Drug:
• Experimental Product 1% Colloidal Oatmeal Balm
Experimental Product 1% Colloidal Oatmeal Balm

Locations

Country	Name	City	State
United States	Stephens & Associates (Colorado Research Center)	Colorado Springs	Colorado
United States	Stephens & Associates (Texas Reserach Center)	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 1: Screening [Day -2]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: Baseline [Day 0] Pre-Treatment and Immediately Post-Treatment	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: 1 hour post application [Day 0]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: 2 hours post application [Day 0]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: 3 hours post application [Day 0]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: 4 hours post application [Day 0]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: 5 hours post application [Day 0]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 2: 6 hours post application [Day 0]	No
Primary	Itch assessment: 10 cm Visual Analog Scale (VAS)	The severity of the itch will be assessed by subject using a 10cm VAS scale. The VAS will follow the following scale: 0 indicates "No itch" and 10 indicates "Severe Itch".	Visit 3: Day 7	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken before and after product treatment.	Visit 2: Baseline [Day 0] Pre-Treatment and Immediately Post-Treatment	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment.	Visit 2: 1 hour post application [Day 0]	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment.	Visit 2: 2 hours post application [Day 0]	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment.	Visit 2: 3 hours post application [Day 0]	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment.	Visit 2: 4 hours post application [Day 0]	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment.	Visit 2: 5 hours post application [Day 0]	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken after product treatment.	Visit 2: 6 hours post application [Day 0]	No
Secondary	Corneometer measurements	Corneometer will be used to measure moisture content on the skin surface. The measurement has no units but is proportional to the dielectric constant of the surface layers of the skin and increases as the skin becomes hydrated. Measurements will be taken before and after product treatment.	Visit 3: Day 7	No
Secondary	Participant Questionnaire	Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree.	Visit 2: Baseline [Day 0] Pre-Treatment and Immediately Post-Treatment	No
Secondary	Participant Questionnaire	Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree.	Visit 2: 4 hours post application [Day 0]	No
Secondary	Participant Questionnaire	Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree.	Visit 2: 5 hours post application [Day 0]	No
Secondary	Participant Questionnaire	Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree.	Visit 2: 6 hours post application [Day 0]	No
Secondary	Participant Questionnaire	Questions to be answered by subjects. Questions include overall look (smooth , healthy) and feel (soft , smooth) of participants' skin; and affected area's look (smooth , healthy) and feel (soft , smooth). Participants will choose from 6 answers: I Don't have an opinion , Strongly Agree , Somewhat Agree , Neither agree or disagree , Somewhat disagree , Strongly Disagree.	Visit 3: [Day 7]	No