Trial Outcomes & Findings for Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis (NCT NCT01093469)

Last Updated: 2018-09-11

Results Overview

This measures the overall response to treatment and quantifies disease on a 6 point scale from "completely clear" to "worsening of disease".0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Day 21

Results posted on

2018-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Aquaphor Healing Ointment Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Overall Study STARTED	13	13	13
Overall Study COMPLETED	13	13	12
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aquaphor Healing Ointment n=13 Participants Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream n=13 Participants Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion n=13 Participants EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	39 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	39 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 21

Outcome measures

Outcome measures
Measure	Aquaphor Healing Ointment n=13 Participants Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream n=13 Participants Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion n=12 Participants EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Investigator Global Assessment of Improvement	2 units on a scale Standard Error 1.7	2 units on a scale Standard Error 2.0	2 units on a scale Standard Error 1.9

Adverse Events

Aquaphor Healing Ointment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Atopiclair Nonsteroidal Cream

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

EpiCream Skin Barrier Emulsion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aquaphor Healing Ointment n=13 participants at risk Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream n=13 participants at risk Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion n=13 participants at risk EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Respiratory, thoracic and mediastinal disorders upper respiratory infection	7.7% 1/13 • Number of events 1	15.4% 2/13 • Number of events 2	0.00% 0/13
Skin and subcutaneous tissue disorders Itching	0.00% 0/13	0.00% 0/13	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders MRSA	0.00% 0/13	0.00% 0/13	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Worsening ATD	7.7% 1/13 • Number of events 1	0.00% 0/13	0.00% 0/13

Additional Information

Dr Alan Fleischer

Wake Forest

Phone: 336-716-3775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60