Atopic Dermatitis (AD)NCT07009483
Effectiveness of Psychodermatologic Educational Modules on Atopic Dermatitis Patient Outcomes
A study testing Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management. in people with Atopic Dermatitis (AD), run by University of Alberta at 3 sites in Canada.
Trial summary
In a previous part of this study, we created educational modules about the psychodermatology of inflammatory skin conditions, with a particular emphasis on atopic dermatitis, for patients. These modules will empower patients to better manage both the psychological and physical aspects of their skin conditions. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesCanada
- Study dates
- 2 Jun 2025to 17 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New diagnosis or follow-up for previous diagnosis of Atopic Dermatitis.
- Reliable internet access to be able to access the e-modules.
- Able to speak English at a level required to understand the content of this study.
- Child participants will be included in this study contingent on the consent of their guardian/caregiver(s).
- Age range of eligible participants: Age 4 years and older.
Who cannot join
- Does not have a new diagnosis or follow-up for previous diagnosis of Atopic Dermatitis.
- Unable to access and/or navigate e-modules with reasonable support/instruction.
- Unable to speak English at a level required to understand the content of this study.
- Unable to provide informed consent.
- Less than 4 years of age.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Rao Dermatology
Edmonton, Alberta, T6G 1C3
Kaye Edmonton Clinic
Edmonton, Alberta, T6G 1Z1
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
About this study
In a previous part of this study, we created educational modules about the psychodermatology of inflammatory skin conditions, with a particular emphasis on atopic dermatitis, for patients. These modules will empower patients to better manage both the psychological and physical aspects of their skin conditions. As part of this project, we aim to conduct a clinical trial to determine the effectiveness of these modules on eczema severity and health-related quality of life in patients. We hope to use these findings to develop and disseminate accessible educational material on the psychological aspects of dermatologic care.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management.
- Keywords
- Atopic Dermatitis, Dermatology, Psychodermatology, Patient Education
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management.Behavioural
Provision of online patient educational modules (in addition to patients receiving regular clinical action/ appointments at the Kaye Edmonton Clinic, the Stollery Children's Hospital, and the Rao Dermatology Clinic for Atopic Dermatitis).
| Study group | Role | What they receive |
|---|---|---|
| Educational Module Arm | Experimental | This arm consists of participants living with atopic dermatitis that will be trialing our educational modules. In addition to receiving standard medical care, they will be asked to complete these modules throughout the duration of the study period. Receives: Behavioral: Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management. |
| Control Arm | No intervention | This arm will consist of participants living with atopic dermatitis. They will receive standard medical care, but will not be given access to the educational modules until the study period has been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
Quality of Life will be measured using the Dermatology Life Quality Index (DLQI). The scores range from 0 to 30 (higher score indicative of worse outcomes)
Measured: Baseline, 4 weeks, and 12 weeks
Secondary outcomes (1)
Eczema Disease Severity
Eczema Disease Severity will be measures using the Patient-Oriented SCORing for Atopic Dermatitis (PO-SCORAD). Scores range between 0 and 103 points (higher score indicative of worse outcomes)
Measured: Baseline, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start2 Jun 2025
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Dytoc, MD, PhD, FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009483
- Sponsor's protocol ID
- Pro00153557
- Status last verified
- Sep 2026
- First submitted
- 29 May 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not necessary
Publications
Liu C, Chan M, Beard V, Mathura P, Dytoc M. Beyond Skin Deep: case-based online modules to teach multidisciplinary care in dermatology among clerkship students. BMC Med Educ. 2023 Feb 4;23(1):90. doi: 10.1186/s12909-023-04072-z.
PubMed 36739386Verma L, Turk T, Dennett L, Dytoc M. Teledermatology in Atopic Dermatitis: A Systematic Review. J Cutan Med Surg. 2024 Mar-Apr;28(2):153-157. doi: 10.1177/12034754231223694. Epub 2024 Jan 11.
PubMed 38205736Odeshi O, Turk T, Fiorillo L, Lowe S, Dytoc M. Teledermatology Versus In-Person Visits for the Follow-Up of Atopic Dermatitis Patients. J Cutan Med Surg. 2024 Jul-Aug;28(4):346-351. doi: 10.1177/12034754241253192. Epub 2024 May 28.
PubMed 38807447Turk T, Fujiwara E, Abba-Aji A, Mathura P, Dytoc M. Psychodermatology in Canada: A National Survey Assessment of Dermatologists' Perception, Practice Patterns, and Challenges. J Cutan Med Surg. 2021 May-Jun;25(3):249-256. doi: 10.1177/1203475420977473. Epub 2020 Dec 2.
PubMed 34039041Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, Ong PY, Chiesa Fuxench ZC, Simpson EL. Symptoms and diagnosis of anxiety and depression in atopic dermatitis in U.S. adults. Br J Dermatol. 2019 Sep;181(3):554-565. doi: 10.1111/bjd.17683. Epub 2019 Mar 5.
PubMed 30838645Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, Simpson EL, Ong PY, Chiesa Fuxench ZC. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):340-347. doi: 10.1016/j.anai.2018.07.006. Epub 2018 Jul 16.
PubMed 30025911Dalgard FJ, Gieler U, Tomas-Aragones L, Lien L, Poot F, Jemec GBE, Misery L, Szabo C, Linder D, Sampogna F, Evers AWM, Halvorsen JA, Balieva F, Szepietowski J, Romanov D, Marron SE, Altunay IK, Finlay AY, Salek SS, Kupfer J. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015 Apr;135(4):984-991. doi: 10.1038/jid.2014.530. Epub 2014 Dec 18.
PubMed 25521458
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Psychodermatologic Educational Modules on Atopic Dermatitis Patient Outcomes
- ClinicalTrials.gov ID
- NCT07009483
- Acronym / sponsor ID
- Pro00153557
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Atopic Dermatitis, Dermatology, Psychodermatology, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 6 Jun 2025 (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.
In a previous part of this study, we created educational modules about the psychodermatology of inflammatory skin conditions, with a particular emphasis on atopic dermatitis, for patients. These modules will empower patients to better manage both the psychological and physical aspects of their skin conditions. As part of this project, we aim to conduct a clinical trial to determine the effectiveness of these modules on eczema severity and health-related quality of life in patients. We hope to use these findings to develop and disseminate accessible educational material on the psychological aspects of dermatologic care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Module Arm | Experimental | Behavioral: Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management.This arm consists of participants living with atopic dermatitis that will be trialing our educational modules. In addition to receiving standard medical care, they will be asked to complete these modules throughout the duration of the study period. |
| Control Arm | No intervention | –This arm will consist of participants living with atopic dermatitis. They will receive standard medical care, but will not be given access to the educational modules until the study period has been completed. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- New diagnosis or follow-up for previous diagnosis of Atopic Dermatitis.
- Reliable internet access to be able to access the e-modules.
- Able to speak English at a level required to understand the content of this study.
- Child participants will be included in this study contingent on the consent of their guardian/caregiver(s).
- Age range of eligible participants: Age 4 years and older.
Key exclusion criteria (5 listed)
- Does not have a new diagnosis or follow-up for previous diagnosis of Atopic Dermatitis.
- Unable to access and/or navigate e-modules with reasonable support/instruction.
- Unable to speak English at a level required to understand the content of this study.
- Unable to provide informed consent.
- Less than 4 years of age.
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 |
|---|---|---|
| Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management.Provision of online patient educational modules (in addition to patients receiving regular clinical action/ appointments at the Kaye Edmonton Clinic, the Stollery Children's Hospital, and the Rao Dermatology Clinic for Atopic Dermatitis). | Behavioural | Educational Module Arm |
Primary outcome
Health-Related Quality of Life
Time frame: Baseline, 4 weeks, and 12 weeks
Quality of Life will be measured using the Dermatology Life Quality Index (DLQI). The scores range from 0 to 30 (higher score indicative of worse outcomes)
1 secondary outcome
Eczema Disease Severity
Time frame: Baseline, 4 weeks, and 12 weeks
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 23 Sep 2026.
- Background: PubMed 36739386Liu C, Chan M, Beard V, Mathura P, Dytoc M. Beyond Skin Deep: case-based online modules to teach multidisciplinary care in dermatology among clerkship students. BMC Med Educ. 2023 Feb 4;23(1):90. doi: 10.1186/s12909-023-04072-z.
- Background: PubMed 38205736Verma L, Turk T, Dennett L, Dytoc M. Teledermatology in Atopic Dermatitis: A Systematic Review. J Cutan Med Surg. 2024 Mar-Apr;28(2):153-157. doi: 10.1177/12034754231223694. Epub 2024 Jan 11.
- Background: PubMed 38807447Odeshi O, Turk T, Fiorillo L, Lowe S, Dytoc M. Teledermatology Versus In-Person Visits for the Follow-Up of Atopic Dermatitis Patients. J Cutan Med Surg. 2024 Jul-Aug;28(4):346-351. doi: 10.1177/12034754241253192. Epub 2024 May 28.
- Background: PubMed 34039041Turk T, Fujiwara E, Abba-Aji A, Mathura P, Dytoc M. Psychodermatology in Canada: A National Survey Assessment of Dermatologists' Perception, Practice Patterns, and Challenges. J Cutan Med Surg. 2021 May-Jun;25(3):249-256. doi: 10.1177/1203475420977473. Epub 2020 Dec 2.
- Background: PubMed 30838645Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, Ong PY, Chiesa Fuxench ZC, Simpson EL. Symptoms and diagnosis of anxiety and depression in atopic dermatitis in U.S. adults. Br J Dermatol. 2019 Sep;181(3):554-565. doi: 10.1111/bjd.17683. Epub 2019 Mar 5.
- Background: PubMed 30025911Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, Simpson EL, Ong PY, Chiesa Fuxench ZC. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):340-347. doi: 10.1016/j.anai.2018.07.006. Epub 2018 Jul 16.
- Background: PubMed 25521458Dalgard FJ, Gieler U, Tomas-Aragones L, Lien L, Poot F, Jemec GBE, Misery L, Szabo C, Linder D, Sampogna F, Evers AWM, Halvorsen JA, Balieva F, Szepietowski J, Romanov D, Marron SE, Altunay IK, Finlay AY, Salek SS, Kupfer J. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015 Apr;135(4):984-991. doi: 10.1038/jid.2014.530. Epub 2014 Dec 18.
- Individual participant dataSharing planned: No. Not necessary
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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.
Marlene Dytoc, MD, PhD, FRCPC principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management. in people with Atopic Dermatitis (AD), run by University of Alberta at 3 sites in Canada.
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 5 inclusion and 5 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Health-Related Quality of Life (time frame: Baseline, 4 weeks, and 12 weeks). 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 NCT07009483, which also lists 7 linked publications.
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 23 Sep 2026.