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RecruitingNCT02945345CDASIUpdated Mar 30, 2026

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

An observational study in Dermatomyositis, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by University of Pennsylvania · Observational

From the registry’s dates

  • Started Jun 2008; still recruiting 18 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Dermatomyositis

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03

In context

Dermatomyositis

171 studies on the registry are indexed under Dermatomyositis; 61 are open to participants now.

This study's planned enrollment of 300 is above the median of 183 across 40 observational studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients who have been diagnosed with dermatomyositis.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Cutaneous Dermatomyositis Disease Area and Severity Index

    Disease severity tool

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

Secondary outcomes

  1. Skin quality of life tool

    Quality of life tool

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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02945345
Lead sponsor
University of Pennsylvania
Responsible party
Victoria Werth (MD and Principal Investigator, University of Pennsylvania) — Principal investigator
First posted
Oct 26, 2016
Start date
Jun 2008
Primary completion
Jan 2, 2030 (estimated)
Completion
Jan 2, 2030 (estimated)
Last update
Mar 30, 2026

Study contacts

Victoria Werth, MD
Contact
werth@pennmedicine.upenn.edu
215-615-2940
Joyce Okawa, RN
Contact
joyce.okawa@pennmedicine.upenn.edu
215-615-2940

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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