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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquaphor Healing Ointment | Experimental | Aquaphor Healing Ointment three times daily to atopic dermatitis |
|
| Atopiclair Nonsteroidal Cream | Active Comparator | Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis |
|
| EpiCream Skin Barrier Emulsion | Active Comparator | EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atopiclair Nonsteroidal Cream | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment of Improvement | 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 | Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Fleischer, MD | Wake Forest University Health Sciences Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21533301 | Derived | Miller DW, Koch SB, Yentzer BA, Clark AR, O'Neill JR, Fountain J, Weber TM, Fleischer AB Jr. An over-the-counter moisturizer is as clinically effective as, and more cost-effective than, prescription barrier creams in the treatment of children with mild-to-moderate atopic dermatitis: a randomized, controlled trial. J Drugs Dermatol. 2011 May;10(5):531-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aquaphor Healing Ointment | Aquaphor Healing Ointment three times daily to atopic dermatitis |
| FG001 | Atopiclair Nonsteroidal Cream | Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis |
| FG002 | EpiCream Skin Barrier Emulsion | EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aquaphor Healing Ointment | Aquaphor Healing Ointment three times daily to atopic dermatitis |
| BG001 | Atopiclair Nonsteroidal Cream | Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Global Assessment of Improvement | 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 | Posted | Median | Standard Error | units on a scale | Day 21 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aquaphor Healing Ointment | Aquaphor Healing Ointment three times daily to atopic dermatitis |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alan Fleischer | Wake Forest | 336-716-3775 | adclark@wakehalth.edu |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C530270 | MAS063DP |
| C539259 | EpiCeram |
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| Aquaphor Healing Ointment |
| Other |
|
| EpiCeram | Drug |
|
|
| BG002 | EpiCream Skin Barrier Emulsion | EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis |
| OG002 | EpiCream Skin Barrier Emulsion | EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis |
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Atopiclair Nonsteroidal Cream | Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis | 0 | 13 | 2 | 13 |
| EG002 | EpiCream Skin Barrier Emulsion | EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis | 0 | 13 | 2 | 13 |
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| MRSA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Worsening ATD | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |