Phase 2
N=53
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02691507 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline in the Itch Assessment Score Immediately Following Treatment — 1.93; 2.64 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EpiCeram Skin Barrier Emulsion (Device); Experimental Product 1% Colloidal Oatmeal Balm (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Itch Assessment Score Immediately Following Treatment |
1.93; 2.64 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 1 Hour After Treatment |
3.00; 3.08 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 2 Hours After Treatment |
3.46; 3.65 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 3 Hours After Treatment |
3.93; 4.88 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 4 Hours After Treatment |
3.85; 4.92 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 5 Hours After Treatment |
4.06; 5.25 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 6 Hours After Treatment |
4.07; 5.55 | <0.001 sig |
| PRIMARY Change From Baseline in the Itch Assessment Score 7 Days After Treatment |
4.22; 6.53 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment |
48.26; 21.71 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment |
27.00; 7.84 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment |
23.20; 7.32 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment |
21.05; 8.07 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment |
19.65; 5.75 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment |
21.48; 7.31 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment |
18.71; 6.05 | <0.001 sig |
| SECONDARY Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment |
21.01; 7.99 | <0.001 sig |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin |
7.5; 0; 7.5; 0; 7.5; 0 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin |
10.0; 7.7; 10.0; 23.1; 5.0; 0 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin |
2.5; 0; 2.5; 0; 10.0; 7.7 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin |
15.0; 0; 5.0; 7.7; 12.5; 30.8 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin |
0; 0; 5.0; 0; 7.5; 0 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin |
7.5; 7.7; 10.0; 7.7; 7.5; 7.7 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Soft Skin |
2.5; 0; 2.5; 7.7; 10.0; 15.4 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days |
2.5; 0; 7.5; 0; 35.0; 23.1 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days |
2.5; 7.7; 0; 0; 22.5; 15.4 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days |
5.0; 0; 25.0; 23.1; 15.0; 15.4 | — |
| SECONDARY Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days |
2.5; 0; 2.5; 0; 27.5; 7.7 | — |
| SECONDARY Participant Questionnaire Immediately After Treatment - Product Fast Absorbing |
22.5; 53.8; 42.5; 38.5; 15.0; 0 | — |
| SECONDARY Participant Questionnaire Immediately After Treatment - Calm Skin |
30.0; 53.8; 37.5; 38.5; 15.0; 7.7 | — |
| SECONDARY Participant Questionnaire Immediately After Treatment - Moisturized Skin |
42.5; 38.5; 40.0; 46.2; 15.0; 7.7 | — |
| SECONDARY Participant Questionnaire Immediately After Treatment - Product Does Not Sting |
50.0; 53.8; 32.5; 7.7; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture |
55.0; 38.5; 25.0; 46.2; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft |
40.0; 46.2; 45.0; 38.5; 7.5; 0 | — |
| SECONDARY Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture |
60.0; 61.5; 27.5; 30.8; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft |
47.5; 53.8; 35.0; 30.8; 2.5; 7.7 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture |
60.0; 38.5; 27.5; 53.8; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Calms Skin |
47.5; 61.5; 35.0; 30.8; 7.5; 7.7 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin |
52.5; 53.8; 27.5; 38.5; 12.5; 7.7 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin |
35.0; 38.5; 30.0; 38.5; 15.0; 7.7 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Shield for Skin |
37.5; 38.5; 37.5; 61.5; 17.5; 0 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized |
57.5; 46.2; 27.5; 38.5; 2.5; 7.7 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable |
42.5; 61.5; 35.0; 15.4; 5.0; 7.7 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft |
50.0; 53.8; 30.0; 30.8; 10.0; 0 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth |
45.0; 53.8; 32.5; 30.8; 7.5; 0 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin |
35.0; 23.1; 40.0; 46.2; 17.5; 15.4 | — |
| SECONDARY Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin |
22.5; 23.1; 27.5; 30.8; 40.0; 30.8 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Skin Feels Calm |
60.0; 66.7; 32.5; 33.3; 0; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin |
55.0; 83.3; 32.5; 16.7; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking |
65.0; 66.7; 20.0; 25.0; 5.0; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin |
42.5; 50.0; 32.5; 41.7; 7.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture |
65.0; 50.0; 22.5; 41.7; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Shield for Skin |
52.5; 66.7; 30.0; 25.0; 12.5; 8.3 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized |
72.5; 50.0; 22.5; 50.0; 0; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable |
57.5; 41.7; 22.5; 58.3; 5.0; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets |
42.5; 83.3; 25.0; 16.7; 10.0; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Skin Feels Soft |
65.0; 50.0; 27.5; 50.0; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Moisturized All Day |
67.5; 33.3; 17.5; 50.0; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Slept Better |
45.0; 41.7; 30.0; 58.3; 17.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth |
60.0; 66.7; 27.5; 25.0; 2.5; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin |
33.3; 33.3; 56.4; 50.0; 5.1; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Skin on Waking |
32.5; 8.3; 30.0; 58.3; 27.5; 25.0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Degree of Sleep |
45.0; 50.0; 30.0; 50.0; 20.0; 0 | — |
| SECONDARY Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin |
25.0; 25.0; 37.5; 33.3; 17.5; 33.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02691507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.