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NCT Number: NCT02945345

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

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.

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Key information

Conditions

Dermatomyositis Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cutaneous Dermatomyositis Disease Area and Severity Index

    Time frame: through study completion, an average of 1 year

    Disease severity tool

Secondary outcomes

  1. Skin quality of life tool

    Time frame: through study completion, an average of 1 year

    Quality of life tool

Study contacts

Contact information is provided by the study sponsor or research team.

Joyce Okawa, RN

CONTACT

[email protected]

215-615-2940

Victoria Werth, MD

CONTACT

[email protected]

215-615-2940

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: CDASI

Important dates

Study start
2008
Primary completion
2030
Study completion
2030
First posted
Oct 26, 2016
Registry last updated
Mar 30, 2026

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.

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