Atopic DermatitisNCT01385527
Pediatric Atopic Dermatitis (AD) Internet Survey
A study testing Weekly Internet survey and Topical Triamcinolone in people with Atopic Dermatitis, run by Wake Forest University.
Trial summary
The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Weekly Internet survey and Topical Triamcinolone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to 27 Oct 2014
- 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 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian.
Who cannot join
- Child is less than 2 or greater than 8 years of age.
- Known allergy or sensitivity to topical triamcinolone in the child.
- Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.
About this study
Official title: Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis
The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.
- Conditions
- Atopic Dermatitis
- Being tested
- Weekly Internet survey, Topical Triamcinolone
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Internet surveyBehavioural
Parents will complete a weekly online survey about medication use.
Topical TriamcinoloneDrug
Topical triamcinolone to all affected areas once daily
| Study group | Role | What they receive |
|---|---|---|
| Weekly Internet survey w medication | Experimental | Weekly survey via email plus topical triamcinolone Receives: Behavioral: Weekly Internet survey; Drug: Topical Triamcinolone |
| Topical triamcinolone only | Active comparator | Standard of care Receives: Drug: Topical Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to topical triamcinolone
Measured: 12 weeks
Secondary outcomes (2)
Eczema Area Severity Index
Measured: 12 weeks
Investigator's Global Assessment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completion27 Oct 2014
- Study completion27 Oct 2014
Why it stopped: study was never initiated, No participants enrolled
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385527
- Sponsor's protocol ID
- IRB00016545
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2011
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01385527
- Acronym / sponsor ID
- IRB00016545
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was never initiated, No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- 27 Oct 2014 (actual)
- Study completion
- 27 Oct 2014 (actual)
- First posted
- 30 Jun 2011 (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 evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Internet survey w medication | Experimental | Behavioral: Weekly Internet survey, Drug: Topical TriamcinoloneWeekly survey via email plus topical triamcinolone |
| Topical triamcinolone only | Active comparator | Drug: Topical TriamcinoloneStandard of care |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian.
Key exclusion criteria (4 listed)
- Child is less than 2 or greater than 8 years of age.
- Known allergy or sensitivity to topical triamcinolone in the child.
- Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
- Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.
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 |
|---|---|---|
| Weekly Internet surveyParents will complete a weekly online survey about medication use. | Behavioural | Weekly Internet survey w medication |
| Topical TriamcinoloneTopical triamcinolone to all affected areas once daily | Drug | Topical triamcinolone only, Weekly Internet survey w medication |
Primary outcome
Adherence to topical triamcinolone
Time frame: 12 weeks
2 secondary outcomes
Eczema Area Severity Index
Time frame: 12 weeks
Investigator's Global Assessment
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- 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.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Internet survey and Topical Triamcinolone in people with Atopic Dermatitis, run by Wake Forest University.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adherence to topical triamcinolone (time frame: 12 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 6 Jul 2018.