Atopic DermatitisNCT06412094
Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis
A study testing Access to the "AtopicApp" mobile application and Virtual oversight through the AtopicApp in people with Atopic Dermatitis, run by Avanta Trading Ltd. at 1 site in Russia.
Trial summary
A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores. Read more about this study
- Who is it for?
- Ages 4 months to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Access to the "AtopicApp" mobile application and Virtual oversight through the AtopicApp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2022to 26 Dec 2022
- 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 4 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with AD and their parents that provided an informed consent to participate in the study
Who cannot join
- previous experience with the Atopic App
- participation in affiliated online Atopic School program
- presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.)
- avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Controlled Study of the Effectiveness of Using a Mobile Application in Managing Pediatric Atopic Dermatitis
A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores.
Read the detailed description
Three study groups: a control group that did not use the mobile health Atopic App, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. Upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. Virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app.
Outcome endpoints are objective severity assessment using the SCORAD scale, and subjective assessment of effectiveness using the POEM scale.
- Conditions
- Atopic Dermatitis
- Being tested
- Standard care, Access to the "AtopicApp" mobile application, Virtual oversight through the AtopicApp
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Recommendation of standard treatment plan, according to the clinical severity of the AD, and. are instruction to contact the doctor via messenger for any questions related to treatment recommendations.
Access to the "AtopicApp" mobile applicationBehavioural
Access to the "AtopicApp" mobile application with 1 day after enrollment.
Virtual oversight through the AtopicAppBehavioural
Notification of doctor's virtual oversight through the AtopicApp mobile application.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Sham comparator | Upon enrollment in the study at the end of the screening visit, participants in all groups receive a recommended treatment plan, according to the clinical severity of the AD, and. are instructed to contact the doctor via messenger for any questions related to their treatment. Receives: Other: Standard care |
| Standard care with access to the "AtopicApp" mobile application | Active comparator | Subjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care. Receives: Other: Standard care; Behavioral: Access to the "AtopicApp" mobile application |
| Standard care with access to the "AtopicApp" mobile application with potential virtual oversight | Experimental | The experimental group receives standard medical care, the AtopicApp mobile application, and information about doctor's virtual oversight through the app (monitoring registration and usage). Receives: Other: Standard care; Behavioral: Access to the "AtopicApp" mobile application; Behavioral: Virtual oversight through the AtopicApp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Oriented Eczema Measure (POEM)
A subjective tool that focuses on severity of atopic dermatitis as experienced by the patient. POEM scores can range from 0 to 28 (higher score reflects worse severity)
Measured: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).
SCORAD (SCORing Atopic Dermatitis)
A clinical tool for assessing the disease severity and subjective symptoms of atopic dermatitis. The SCORAD score range is between 0 and 103 points (higher score reflects worse severity).
Measured: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Mar 2022
- Primary completion26 Dec 2022
- Study completion26 Dec 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanta Trading Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Migacheva, MD, PhD, Principal investigator, Samara State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412094
- Sponsor's protocol ID
- 242-SSMU
- Status last verified
- Apr 2024
- First submitted
- 5 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be available to qualified researchers upon request by email to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Controlled Study of the Effectiveness of Using a Mobile Application in Managing Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06412094
- Acronym / sponsor ID
- 242-SSMU
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Avanta Trading Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 14 May 2024 (actual)
- 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.
A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores.
Detailed description
Three study groups: a control group that did not use the mobile health Atopic App, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. Upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. Virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app.
Outcome endpoints are objective severity assessment using the SCORAD scale, and subjective assessment of effectiveness using the POEM scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Standard care | Sham comparator | Other: Standard careUpon enrollment in the study at the end of the screening visit, participants in all groups receive a recommended treatment plan, according to the clinical severity of the AD, and. are instructed to contact the doctor via messenger for any questions related to their treatment. |
| Standard care with access to the "AtopicApp" mobile application | Active comparator | Other: Standard care, Behavioral: Access to the "AtopicApp" mobile applicationSubjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care. |
| Standard care with access to the "AtopicApp" mobile application with potential virtual oversight | Experimental | Other: Standard care, Behavioral: Access to the "AtopicApp" mobile application, Behavioral: Virtual oversight through the AtopicAppThe experimental group receives standard medical care, the AtopicApp mobile application, and information about doctor's virtual oversight through the app (monitoring registration and usage). |
Who may qualify
- Ages
- 4 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with AD and their parents that provided an informed consent to participate in the study
Key exclusion criteria (4 listed)
- previous experience with the Atopic App
- participation in affiliated online Atopic School program
- presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.)
- avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)
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 |
|---|---|---|
| Standard careRecommendation of standard treatment plan, according to the clinical severity of the AD, and. are instruction to contact the doctor via messenger for any questions related to treatment recommendations. | Other | Standard care, Standard care with access to the "AtopicApp" mobile application, Standard care with access to the "AtopicApp" mobile application with potential virtual oversight |
| Access to the "AtopicApp" mobile applicationAccess to the "AtopicApp" mobile application with 1 day after enrollment. | Behavioural | Standard care with access to the "AtopicApp" mobile application, Standard care with access to the "AtopicApp" mobile application with potential virtual oversight |
| Virtual oversight through the AtopicAppNotification of doctor's virtual oversight through the AtopicApp mobile application. | Behavioural | Standard care with access to the "AtopicApp" mobile application with potential virtual oversight |
Primary outcome
Patient Oriented Eczema Measure (POEM)
Time frame: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).
A subjective tool that focuses on severity of atopic dermatitis as experienced by the patient. POEM scores can range from 0 to 28 (higher score reflects worse severity)
SCORAD (SCORing Atopic Dermatitis)
Time frame: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).
A clinical tool for assessing the disease severity and subjective symptoms of atopic dermatitis. The SCORAD score range is between 0 and 103 points (higher score reflects worse severity).
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 14 May 2024.
- Individual participant dataSharing planned: Yes. De-identified IPD will be available to qualified researchers upon request by email to the principal investigator.
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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.
Natalia Migacheva, MD, PhD principal investigator
Samara State Medical 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 Access to the "AtopicApp" mobile application and Virtual oversight through the AtopicApp in people with Atopic Dermatitis, run by Avanta Trading Ltd. at 1 site in Russia.
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: finished, as of the sponsor's last update on 14 May 2024. 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 Russia. 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. Some participants in this study may receive a placebo. 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?
Patient Oriented Eczema Measure (POEM) (time frame: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).). The study lists 2 primary outcomes in all. 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 14 May 2024.