Atopic DermatitisNCT01675232
A Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
A study testing Soak and smear and Dry Smear in people with Atopic Dermatitis, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis). Read more about this study
- Who is it for?
- Ages 2 weeks to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Soak and smear and Dry Smear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet the clinical criteria for the diagnosis of atopic dermatitis
- Have disease over at least 5% of their total body surface area.
- Less than 18 years of age.
- Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
- Parents/guardians able to understand and willing to sign a parental permission form.
- Children between the ages of 7-17 years willing to sign an age-appropriate assent form.
Who cannot join
- Patients who are allergic or intolerant of the topical medications employed in this study.
- Lack of follow-up after initial visit or regimen noncompliance.
- Patients who do not have access to a bathtub.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
The purpose of this study is to investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).
- Conditions
- Atopic Dermatitis
- Being tested
- Soak and smear, Dry Smear
- Keywords
- Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soak and smearOther
Corticosteroid ointment applied to wet skin once a day and dry skin once a day.
Dry SmearOther
Corticosteroid ointment applied to dry skin twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Soak and smear | Active comparator | Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day. Receives: Other: Soak and smear |
| Dry smear | Active comparator | Application of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day. Receives: Other: Dry Smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
Measured: 2 weeks
Secondary outcomes (3)
Effect of corticosteroid ointment application regimens on serum cortisol
Measured: 2 weeks after application of topical corticosteroids
Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen
Measured: 3 months
Adverse effects associated with each corticosteroid application regimen
Characterize and quantify adverse effects associated with each corticosteroid application regimen.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Antaya, Yale University
- Investigators
- Richard J Antaya, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675232
- Sponsor's protocol ID
- HIC-1206010366
- Status last verified
- Jul 2014
- First submitted
- 2 Aug 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator-Blinded Study Comparing the Efficacy of Two Topical Steroid Application Regimens in Pediatric Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01675232
- Acronym / sponsor ID
- HIC-1206010366
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Topical corticosteroid, Pediatric, Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
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 investigate the efficacy of two different corticosteroid ointment application regimens for the treatment of eczema (atopic dermatitis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soak and smear | Active comparator | Other: Soak and smearApplication of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment immediately to wet skin once a day and dry skin once a day. |
| Dry smear | Active comparator | Other: Dry SmearApplication of hydrocortisone 2.5% ointment or triamcinolone acetonide 0.1% ointment to dry skin twice a day. |
Who may qualify
- Ages
- 2 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Meet the clinical criteria for the diagnosis of atopic dermatitis
- Have disease over at least 5% of their total body surface area.
- Less than 18 years of age.
- Families able to comprehend written instructions in English and able to complete questionnaires with assistance if needed.
- Parents/guardians able to understand and willing to sign a parental permission form.
Key exclusion criteria (3 listed)
- Patients who are allergic or intolerant of the topical medications employed in this study.
- Lack of follow-up after initial visit or regimen noncompliance.
- Patients who do not have access to a bathtub.
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 |
|---|---|---|
| Soak and smearCorticosteroid ointment applied to wet skin once a day and dry skin once a day. | Other | Soak and smear |
| Dry SmearCorticosteroid ointment applied to dry skin twice a day. | Other | Dry smear |
Primary outcome
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI)
Time frame: 2 weeks
3 secondary outcomes
Effect of corticosteroid ointment application regimens on serum cortisol
Time frame: 2 weeks after application of topical corticosteroids
Frequency of atopic dermatitis flares in the 3 months following the two-week treatment regimen
Time frame: 3 months
Adverse effects associated with each corticosteroid application regimen
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
Related trials for Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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.
Richard J Antaya, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soak and smear and Dry Smear in people with Atopic Dermatitis, run by Yale University 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 6 inclusion and 3 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 29 Jul 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of corticosteroid application regimen as assessed by the Eczema Area and Severity Index (EASI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2014.