Atopic DermatitisPhase 4NCT01093469
Comparing Aquaphor to Atopiclair and EpiCeram in Children With Mild to Moderate Atopic Dermatitis
A Phase 4 study testing Atopiclair Nonsteroidal Cream, Aquaphor Healing Ointment and EpiCeram in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Atopiclair Nonsteroidal Cream, Aquaphor Healing Ointment and EpiCeram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Atopiclair Nonsteroidal Cream, Aquaphor Healing Ointment, EpiCeram
- Keywords
- Atopic Dermatitis, Wake Forest, Dermatology, Skin, Over-the-counter, Moisturizer, Children
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atopiclair Nonsteroidal CreamDrug
Also called MAS063DP
Aquaphor Healing OintmentOther
EpiCeramDrug
Also called BRC-Cer
| Study group | Role | What they receive |
|---|---|---|
| Aquaphor Healing Ointment | Experimental | Aquaphor Healing Ointment three times daily to atopic dermatitis Receives: Other: Aquaphor Healing Ointment |
| Atopiclair Nonsteroidal Cream | Active comparator | Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis Receives: Drug: Atopiclair Nonsteroidal Cream |
| EpiCream Skin Barrier Emulsion | Active comparator | EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis Receives: Drug: EpiCeram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Fleischer, MD, Principal investigator, Wake Forest University Health Sciences Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093469
- Sponsor's protocol ID
- IRB00009130
- Status last verified
- Aug 2018
- First submitted
- 24 Mar 2010
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21533301
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01093469
- Acronym / sponsor ID
- IRB00009130
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Wake Forest, Dermatology, Skin, Over-the-counter, Moisturizer, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aquaphor Healing Ointment | Experimental | Other: Aquaphor Healing OintmentAquaphor Healing Ointment three times daily to atopic dermatitis |
| Atopiclair Nonsteroidal Cream | Active comparator | Drug: Atopiclair Nonsteroidal CreamAtopiclair Nonsteroidal Cream three times daily to atopic dermatitis |
| EpiCream Skin Barrier Emulsion | Active comparator | Drug: EpiCeramEpiCream Skin Barrier Emulsion three times daily to atopic dermatitis |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atopiclair Nonsteroidal CreamAlso: MAS063DP | Drug | Atopiclair Nonsteroidal Cream |
| Aquaphor Healing Ointment | Other | Aquaphor Healing Ointment |
| EpiCeramAlso: BRC-Cer | Drug | EpiCream Skin Barrier Emulsion |
Primary outcome
Investigator Global Assessment of Improvement
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21533301Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Fleischer, MD principal investigator
Wake Forest University Health Sciences Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atopiclair Nonsteroidal Cream, Aquaphor Healing Ointment and EpiCeram in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment of Improvement (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.