CorEvitas, LLC
Waltham, Massachusetts, 02451, United States
Location status: Recruiting
NCT Number: NCT06238765
Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.
Interested in participating?
Request Info10 year–15 year
All sexes
Observational
Waltham, Massachusetts, 02451, United States
Location status: Recruiting
The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through Study completion until the subject is 18 years
The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.
Time frame: Time Frame: at registry enrollment
Time frame: every 6 months until the subject is 18 years
Score: 0-4, with high score indicating widespread of atopic dermatitis
Time frame: every 6 months until the subject is 18 years
Scale - 0 (Clear/Normal) to 100 (Severe Abnormalities). Lower numbers are for mild abnormalities in a few nails, higher numbers are for more severe changes in many nails
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe.
Time frame: every 6 months until the subject is 18 years
The severity of each sign will be graded on a scale of 0 to 3: (0) None, (1) Mild, (2) Moderate, (3) Severe. For the Overall Score [SCORAD], select a lesion that that is representative of the body and score using the same severity scale
Time frame: every 6 months until the subject is 18 years
This determines the progression & severity of the disease
Time frame: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: every 6 months until the subject is 18 years
Time frame: 6 months until the subject is 18 years
CorEvitas
Network
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07262983
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Bethesda, Maryland, United States
View Trial DetailsNCT04419584
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Hong Kong
View Trial DetailsNCT07467564
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Doha, Qatar
View Trial DetailsNCT07216027
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Northridge, California, United States
View Trial Details