Trial Outcomes & Findings for To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children (NCT NCT00886587)
NCT ID: NCT00886587
Last Updated: 2017-05-23
Results Overview
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
COMPLETED
NA
82 participants
Baseline to Day 43
2017-05-23
Participant Flow
Participant milestones
| Measure |
Investigational Device
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Investigational Device
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
Baseline characteristics by cohort
| Measure |
Investigational Device
n=41 Participants
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
n=41 Participants
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.37 years
STANDARD_DEVIATION 2.90 • n=5 Participants
|
5.56 years
STANDARD_DEVIATION 2.84 • n=7 Participants
|
5.96 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 43Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
Outcome measures
| Measure |
Investigational Device
n=39 Participants
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
n=40 Participants
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
|
-4.97 units on a scale
Standard Error 0.41
|
-5.01 units on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline to Day 15Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).
Outcome measures
| Measure |
Investigational Device
n=35 Participants
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
n=41 Participants
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
|
-3.79 units on a scale
Standard Error 0.41
|
-4.14 units on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline to Day 43Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).
Outcome measures
| Measure |
Investigational Device
n=41 Participants
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
n=41 Participants
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
|
0.78 units on a scale
Standard Error 0.15
|
0.73 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline to Day 43Population: The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
The subject's and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.
Outcome measures
| Measure |
Investigational Device
n=37 Participants
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
n=36 Participants
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
Itch Score on Day 43 - Change From Baseline
|
-3.26 units on a scale
Standard Error 0.33
|
-3.29 units on a scale
Standard Error 0.33
|
Adverse Events
Investigational Device
Atopiclair® Skin and Wound Emulsion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational Device
n=41 participants at risk
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
Atopiclair® Skin and Wound Emulsion
n=41 participants at risk
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
|
|---|---|---|
|
General disorders
Application Site Irritation
|
17.1%
7/41 • Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
26.8%
11/41 • Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
|
General disorders
Application Site Pain
|
22.0%
9/41 • Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
17.1%
7/41 • Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
|
Infections and infestations
Gastroenteritis
|
7.3%
3/41 • Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
2.4%
1/41 • Day 43, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
|
Additional Information
Amisha Parikh-Das, PhD/Study Director
Johnson & Johnson Consumer Inc
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed not to publish the study results without prior sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER