System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT04087629 on ClinicalTrials.gov

StrataCTX® as a Steroid Sparing Device

Official title: Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent

  • Sponsor: Columbia University
  • Enrollment: 70 (Estimated)
  • Study start: 2021-07-07 (Actual)
  • Primary completion: 2027-08-01 (Estimated)
  • Study completion: 2027-08-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Supportive Care

Brief Summary

The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.

Conditions

  • CTCL

Intervention / Treatment

  • Device: StrataCTX® gel

Primary Outcome Measures

  • Change in Pruritus Visual Analogue Scale (VAS) Score (Screening through 3 months)
    The primary objective of this study is to determine whether StrataCTX® gel is effective as a supportive therapy for cutaneous reactions treated with topical steroids as the standard of care. This objective will be measured by the Pruritus Visual Analogue Scale, which measures self-reported itching on a scale of 0 (no itching) (better outcome) to 10 (worst imaginable itch).

Countries

United States

Locations and Investigators

Study Officials