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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01093469
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.

The investigators hypothesize that no statistical difference will exist in the efficacy between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be most cost-effective than Atopiclair or EpiCeram.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Atopiclair Nonsteroidal Cream; Other: Aquaphor Healing Ointment; Drug: EpiCeram	Phase 4

Detailed Description

The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these products. A significant difference exists in the cost of these products; therefore, if our hypothesis is proved correct - that Aquaphor will be just as efficacious as the more expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the overall cost of treating atopic dermatitis.

This is a single center, investigator blinded, randomized, prospective controlled study of subjects with mild to moderate atopic dermatitis. The study is intended to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All subjects will receive active study medication and will return to study center for efficacy and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables. Efficacy will be measured through Investigator's Global Assessment, BSA involvement, Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be calculated as cost in dollars for change in outcome according to EASI, BSA and VAS.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: An Investigator Blinded, Randomized, Controlled Study Comparing the Efficacy and Cost-Effectiveness of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream (MAS063DP) and EpiCeram Skin Barrier Emulsion in Children With Mild to Moderate Atopic Dermatitis
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aquaphor Healing Ointment Aquaphor Healing Ointment three times daily to atopic dermatitis	Other: Aquaphor Healing Ointment
Active Comparator: Atopiclair Nonsteroidal Cream Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	Drug: Atopiclair Nonsteroidal Cream; Other Names: MAS063DP
Active Comparator: EpiCream Skin Barrier Emulsion EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis	Drug: EpiCeram; Other Names: BRC-Cer

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment of Improvement [Day 21]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female with mild to moderate atopic dermatitis, 2-17 years of age, that agree to participate and provide written consent (and assent if applicable)

• Have an investigator Global Assessment of mild to moderate atopic dermatitis (IGA rating of 2-3 in the Investigator Global Assessment)

• Percentage of overall body surface area of involvement (BSA) must be > 1% and may include facial and intertriginous skin.

Exclusion Criteria:

• Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.

• Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.

• Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.

• Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating int he study (oral antihistamines will be allowed, so long as they are neither initiated nor discontinued during the course of this study)

• Amount of disease involvement that would require >60gm of cream in a 1 week period

• Subjects with known allergy or sensitivity to Aquaphor Healing Ointment, Atopiclair or EpiCeram or components therein.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Alan Fleischer, MD, Wake Forest University Health Sciences Department of Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01093469
• Other Study ID Numbers: IRB00009130
• First Posted: Mar 25, 2010
• Last Update Posted: Sep 11, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: Atopic Dermatitis; Wake Forest; Dermatology; Skin; Over-the-counter; Moisturizer; Children
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Decanoic acid; Petrolatum

Study Results

Participant Flow

Arm/Group Title	Aquaphor Healing Ointment	Atopiclair Nonsteroidal Cream	EpiCream Skin Barrier Emulsion
Arm/Group Description	Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Period Title: Overall Study
STARTED	13	13	13
COMPLETED	13	13	12
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Aquaphor Healing Ointment	Atopiclair Nonsteroidal Cream	EpiCream Skin Barrier Emulsion	Total
Arm/Group Description	Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis	Total of all reporting groups
Overall Participants	13	13	13	39
Age (Count of Participants)
<=18 years	13 100%	13 100%	13 100%	39 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 53.8%	7 53.8%	8 61.5%	22 56.4%
Male	6 46.2%	6 46.2%	5 38.5%	17 43.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 15.4%	0 0%	1 7.7%	3 7.7%
Not Hispanic or Latino	11 84.6%	13 100%	12 92.3%	36 92.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 7.7%	0 0%	0 0%	1 2.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 7.7%	6 46.2%	7 53.8%	14 35.9%
White	10 76.9%	7 53.8%	6 46.2%	23 59%
More than one race	1 7.7%	0 0%	0 0%	1 2.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	13 100%	13 100%	39 100%

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment of Improvement
Description	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
Time Frame	Day 21

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aquaphor Healing Ointment	Atopiclair Nonsteroidal Cream	EpiCream Skin Barrier Emulsion
Arm/Group Description	Aquaphor Healing Ointment three times daily to atopic dermatitis	Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis	EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Measure Participants	13	13	12
Median (Standard Error) [units on a scale]	2 (1.7)	2 (2.0)	2 (1.9)

Adverse Events

Arm/Group Title	Aquaphor Healing Ointment		Atopiclair Nonsteroidal Cream		EpiCream Skin Barrier Emulsion
Arm/Group Description	Aquaphor Healing Ointment three times daily to atopic dermatitis		Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis		EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
All Cause Mortality
	Aquaphor Healing Ointment		Atopiclair Nonsteroidal Cream		EpiCream Skin Barrier Emulsion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Aquaphor Healing Ointment		Atopiclair Nonsteroidal Cream		EpiCream Skin Barrier Emulsion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Aquaphor Healing Ointment		Atopiclair Nonsteroidal Cream		EpiCream Skin Barrier Emulsion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/13 (15.4%)		2/13 (15.4%)		2/13 (15.4%)
Respiratory, thoracic and mediastinal disorders
upper respiratory infection	1/13 (7.7%)	1	2/13 (15.4%)	2	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Itching	0/13 (0%)	0	0/13 (0%)	0	1/13 (7.7%)	1
MRSA	0/13 (0%)	0	0/13 (0%)	0	1/13 (7.7%)	1
Worsening ATD	1/13 (7.7%)	1	0/13 (0%)	0	0/13 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.