Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT02945345

Conditions

Dermatomyositis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Dermatomyositis

Study ID

NCT02945345

Start date

Jun, 2008

Status verified date

Mar, 2026

Completion date

Jan 2, 2030

Anticipated

Primary completion date

Jan 2, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Cutaneous Dermatomyositis Disease Area and Severity Index [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Victoria Werth, MD

215-615-2940werth@pennmedicine.upenn.edu

Joyce Okawa, RN

215-615-2940joyce.okawa@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Victoria P Werth, MD

215-615-2940werth@pennmedicine.upenn.edu

Joyce Okawa, RN

215-615-2940joyce.okawa@pennmedicine.upenn.edu

Principal Investigator:

Victoria P Werth, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-30.