A Phase 4 interventional study of Atopiclair Nonsteroidal Cream and Aquaphor Healing Ointment in Atopic Dermatitis, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 39 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aquaphor Healing Ointment three times daily to atopic dermatitis
Other: Aquaphor Healing Ointment
Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
Drug: Atopiclair Nonsteroidal Cream
EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Drug: EpiCeram
Also known as: MAS063DP
Also known as: BRC-Cer
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
Time frame: Day 21
| Milestone | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion |
|---|---|---|---|
| Started | 13 | 13 | 13 |
| Completed | 13 | 13 | 12 |
| Not completed | 0 | 0 | 1 |
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
| units on a scale | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion |
|---|---|---|---|
| Investigator Global Assessment of Improvement | 2 ± 1.7 | 2 ± 2.0 | 2 ± 1.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aquaphor Healing Ointment | — | 0/13 (0%) | 2/13 (15.4%) |
| Atopiclair Nonsteroidal Cream | — | 0/13 (0%) | 2/13 (15.4%) |
| EpiCream Skin Barrier Emulsion | — | 0/13 (0%) | 2/13 (15.4%) |
| Event | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion |
|---|---|---|---|
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 1/13 | 2/13 | 0/13 |
| ItchingSkin and subcutaneous tissue disorders | 0/13 | 0/13 | 1/13 |
| MRSASkin and subcutaneous tissue disorders | 0/13 | 0/13 | 1/13 |
| Worsening ATDSkin and subcutaneous tissue disorders | 1/13 | 0/13 | 0/13 |
| Age, Categorical(Participants) | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion | Total |
|---|---|---|---|---|
| <=18 years | 13 | 13 | 13 | 39 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion | Total |
|---|---|---|---|---|
| Female | 7 | 7 | 8 | 22 |
| Male | 6 | 6 | 5 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 1 | 3 |
| Not Hispanic or Latino | 11 | 13 | 12 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 6 | 7 | 14 |
| White | 10 | 7 | 6 | 23 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Aquaphor Healing Ointment | Atopiclair Nonsteroidal Cream | EpiCream Skin Barrier Emulsion | Total |
|---|---|---|---|---|
| United States | 13 | 13 | 13 | 39 |
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences