ClinicalTrials.gov record NCT02945345

Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an ongoing database (registry) study that collects clinical scores and quality-of-life information for adults with dermatomyositis using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI). The study records disease severity, treatments, and patient-reported outcomes to describe clinical course and quality of life. Collected data will be analyzed over a five-year period.

What it is studying. The study evaluates the CDASI as a clinical outcome measure for skin disease in dermatomyositis and collects related quality-of-life and clinical data to characterize disease course and responses to treatment.

What the researchers hope to learn. To validate and evaluate the CDASI as a tool for measuring skin disease severity and responsiveness, to compare it with other instruments, and to better describe treatments, clinical changes, and quality-of-life impacts in dermatomyositis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis. The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL). The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Gender/Age: Males or females above 18 years old
  • Diagnosis: Cutaneous Dermatomyositis
  • Subjects able to give informed consent

Exclusion criteria

  • Subjects without cutaneous DM
  • Penn employees
  • Penn students
  • Cognitively impaired persons

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have their skin disease measured using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) and complete skin quality-of-life questionnaires. Clinical information and other assessment responses will be collected and entered into a research database. Follow-up assessments are expected over the study period (the record lists an average of about 1 year of participation). The registry record does not list any invasive procedures.

How the study is structured. A prospective observational registry (cohort) that follows adults with dermatomyositis. Participants have CDASI scores and skin quality-of-life assessments recorded through study completion (about one year on average), and the collected data are analyzed as part of the database.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
June 2008
Primary completion
Jan 2, 2030 (estimated)
Study completion
Jan 2, 2030 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
Mar 30, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Pennsylvania
Principal investigator
Victoria Werth, MD and Principal Investigator
University of Pennsylvania

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

outcome measure
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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