Clinical trial NCT02691507: Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema, Itchy Skin
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2016-02-25
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Itch Assessment Score Immediately Following Treatment
timeFrame: Baseline to immediately following treatment
measure: Change From Baseline in the Itch Assessment Score 1 Hour After Treatment
timeFrame: Baseline to one hour after treatment
measure: Change From Baseline in the Itch Assessment Score 2 Hours After Treatment
timeFrame: Baseline to two hours after treatment
measure: Change From Baseline in the Itch Assessment Score 3 Hours After Treatment
timeFrame: Baseline to three hours after treatment
measure: Change From Baseline in the Itch Assessment Score 4 Hours After Treatment
timeFrame: Baseline to four hours after treatment
measure: Change From Baseline in the Itch Assessment Score 5 Hours After Treatment
timeFrame: Baseline to five hours after treatment
measure: Change From Baseline in the Itch Assessment Score 6 Hours After Treatment
timeFrame: Baseline to six hours after treatment
measure: Change From Baseline in the Itch Assessment Score 7 Days After Treatment
timeFrame: Baseline to seven days after treatment
Secondary outcomes:
measure: Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
timeFrame: Baseline to Immediately following treatment
measure: Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment
timeFrame: Baseline to one hour after treatment
measure: Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment
timeFrame: Baseline to two hours after treatment
measure: Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment
timeFrame: Baseline to three hours after treatment
measure: Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment
timeFrame: Baseline to four hours after treatment
measure: Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment
timeFrame: Baseline to five hours after treatment
measure: Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment
timeFrame: Baseline to six hours after treatment
measure: Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment
timeFrame: Baseline to seven days after treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Soft Skin
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days
timeFrame: 0 Days - Pre-treatment
measure: Participant Questionnaire Immediately After Treatment - Product Fast Absorbing
timeFrame: 0 Days - Immediately after treatment
measure: Participant Questionnaire Immediately After Treatment - Calm Skin
timeFrame: 0 Days - Immediately after treatment
measure: Participant Questionnaire Immediately After Treatment - Moisturized Skin
timeFrame: 0 Days - Immediately after treatment
measure: Participant Questionnaire Immediately After Treatment - Product Does Not Sting
timeFrame: 0 Days - Immediately after treatment
measure: Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture
timeFrame: Four hours after treatment
measure: Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft
timeFrame: Four hours after treatment
measure: Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture
timeFrame: Five hours after treatment
measure: Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft
timeFrame: Five hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Calms Skin
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Shield for Skin
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin
timeFrame: Six hours after treatment
measure: Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin
timeFrame: Six hours after treatment
measure: Participant Questionnaire 7 Days After Treatment - Skin Feels Calm
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Shield for Skin
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Skin Feels Soft
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Moisturized All Day
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Slept Better
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Skin on Waking
timeFrame: Seven days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Degree of Sleep
timeFrame: 7 days after treatment
measure: Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin
timeFrame: Seven days after treatment
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Stephens & Associates (Colorado Research Center)
state: Colorado
city: Richardson
country: United States
facility: Stephens & Associates (Texas Reserach Center)
state: Texas
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Amisha Parikh-Das, PhD
role: STUDY_DIRECTOR
affiliation: Stephens & Associates, Inc (Texas Research Center)
name: Lily Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stephens & Associates, Inc (Colorado Research Center)
name: Kun M Qian, MD
role: PRINCIPAL_INVESTIGATOR
References: