This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorSanofi

About this trial

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.

The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged more than or equal to (≥) 12 years at the time of consent.

Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.

Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)

Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.

Disqualifiers

Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.

Insufficient understanding of the study by the patient and/or parent/guardian.

Trial population

Patients with any atopic dermatitis severity will be invited to enroll in the registry after the decision has been made to initiate a new systemic medication for the first time or switch systemic therapies. Inclusion in the registry will not influence a patient's treatment course.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Atopic Dermatitis

Trial outcomes

Primary outcomes

1

Number of Participants Utilizing Atopic Dermatitis (AD) Treatment

The number (and percentage) of participants taking AD treatments and treatments per patient will be described.

Time frame
Baseline to up to 60 months
2

Duration of Treatment

The duration of AD treatments will be summarized descriptively.

Time frame
Baseline to up to 60 months
3

AD Treatment Sequences

The ordering of AD treatments will be summarized descriptively.

Time frame
Baseline to up to 60 months
4

Number of Participants Initiating AD Treatments with Reasons

The number (and percentage) of patients initiating AD treatment and reasons for initiation will be summarized descriptively.

Time frame
Baseline to up to 60 months

Secondary outcomes

1

Sociodemographic characteristics of Participants

Demographics characteristics including age, sex, body weight, height, geographic region, education level, employment status, smoking and alcohol status will be collected.

Time frame
Baseline
2

Ethnic Origin in Combination with Fitzpatrick Scale

The Fitzpatrick Skin Type Scale was developed based on an individual's reaction to sun exposure and will be completed by the Investigator. Skin types range from I - VI, with scores of I indicating the palest skin tone with no inherent melanin pigmentation, and VI indicating the darkest skin tone with significant amount of melanin.

Time frame
Baseline
3

Disease characteristics of Participants

History of AD (including date of diagnosis, age of onset, specialty of provider who diagnosed condition), AD morphology, including but not limited to, patches, plaques, prurigo nodules, lichenoid papules, perifollicular papules, nummular lesions, and psoriasiform lesions and family history of AD and comorbidities will be collected.

Time frame
Baseline
4

Change from Baseline in Dermatology-specific Quality of Life Measure with Dermatology Life Quality Index (DLQI)

DLQI is calculated by summing the score of each question resulting in a maximum score of 30 and a minimum score of 0 (higher scores indicate quality of life is more impaired).

Time frame
Baseline to up to 60 months

Other outcomes

Sponsors and contacts

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