Atopic Dermatitis, Eczema, Skin Diseases
Conditions
Brief summary
Atopic dermatitis (eczema) is a complicated skin condition. In fact, it represents many different underlying problems. These include abnormalities in the skin barrier, the immune system and the ability to handle different bacteria. Despite many recent gains in the understanding of eczema, a lot needs to be learned. There is little evidence to select between some of the older treatments that are available now. Even the newest targeted therapy does not clear most patients' skin. In order to improve the understanding of eczema, how to treat it now, and to enable discovery of new treatments, the investigators plan to enroll patients into a large study at three centres in Canada (University of Toronto, McGill University and University of British Columbia). The study is called the Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI). In this study, the investigators will collect data on how severe participants' eczema is and what treatments they use. For participants who give permission, the investigators will collect blood and skin biopsy samples to study the mechanisms underlying their disease. The investigators will test to see which form of phototherapy (Broadband or Narrowband Ultraviolet B phototherapy) works best for eczema in a randomized clinical trial. The investigators will also use advanced imaging techniques to visualize the skin. This trial registry entry, including the description of the treatment arms and outcomes, refer to the nested BROadband vs Narrowband photoTherapy for Eczema clinical trial.
Interventions
Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
DEVICEBroadband UVB phototherapy
Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
Sponsors
Women's College Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre
University of British Columbia
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Atopic dermatitis according to the Hanifin and Rajka criteria. 2. Validated Investigator Global Assessment score of 3 or 4 out of 4 3. Eczema Area and Severity Index (EASI) score ≥7.1 4. Moderate to severe disease as above despite an adequate trial of topical therapy.
Exclusion criteria
1. Treatment with phototherapy or oral systemic immune-modulating agents (cyclosporine, methotrexate, azathioprine, mycophenolate) less than 30 days before baseline. 2. Treatment with systemic biologic (dupilumab) or experimental therapeutic less than 90 days before baseline. 3. Current treatment with oral or intramuscular corticosteroids within 30 days prior to baseline. Topical, intralesional or inhaled corticosteroids are allowed. 4. Participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline (95% CrI) in the Eczema Area and Severity Index (EASI) | Week 12 | The EASI measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 72. Higher scores indicate worse disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline | Week 12 | The Investigator Global Assessment (vIGA) measures clinical signs of atopic dermatitis. The minimum value is 0, the maximum is 4. Higher scores indicate worse disease. |
| Absolute Change From Baseline (95% CrI) in the Patient Oriented Eczema Measure (POEM) | Week 12 | The POEM measures symptoms of atopic dermatitis. The minimum value is 0, the maximum is 28. Higher scores indicate more frequent symptoms. |
| Absolute Change From Baseline (95% CrI) in the Peak Pruritus Numeric Rating Scale (PP-NRS) | Week 12 | The PP-NRS measures itch. The minimum value is 0, the maximum is 10. Higher scores indicate worse itch. |
| Absolute Change From Baseline (95% CrI) in the Dermatology Life Quality Index (DLQI) | Week 12 | The DLQI measures skin-specific quality of life. The minimum value is 0, the maximum is 30. Higher scores indicate worse impact on quality of life. |
| Absolute Change From Baseline (95% CrI) in the Recap of Atopic Eczema (RECAP) | Week 12 | The RECAP measures atopic dermatitis control. The minimum value is 0, the maximum is 28. Higher scores indicate worse atopic dermatitis control. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAaron M Drucker
Women's College Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 14.1 |
| Body Surface Area (BSA) involved with eczema | 32.5 percentage of body surface area STANDARD_DEVIATION 21.5 |
| Dermatology Life Quality Index (DLQI) | 14.7 units on a scale STANDARD_DEVIATION 7.1 |
| Eczema Area and Severity Index (EASI) | 17.4 units on a scale STANDARD_DEVIATION 8.8 |
| Patient-Oriented Eczema Measure (POEM) | 18.6 units on a scale STANDARD_DEVIATION 6 |
| Peak Pruritus Numerical Rating Scale (PP-NRS) | 7 units on a scale STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Recap of Atopic Eczema (RECAP) | 17.4 units on a scale STANDARD_DEVIATION 6.4 |
| Region of Enrollment Canada | 66 participants |
| Sex/Gender, Customized Gender (female, male) Female | 19 Participants |
| Sex/Gender, Customized Gender (female, male) Male | 15 Participants |
| Validated Investigator Global Assessment for Atopic Dermatitis (vIGA- AD) 3 (Moderate) | 45 Participants |
| Validated Investigator Global Assessment for Atopic Dermatitis (vIGA- AD) 4 (Severe) | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 |
| other Total, other adverse events | 0 / 34 | 4 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 |
Outcome results
None listed