RecruitingNot ApplicableNCT04087629

StrataCTX® as a Steroid Sparing Device

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


Sponsor

Columbia University

Enrollment

70 participants

Start Date

Jul 7, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age ≥ 18 years
  • Ability to sign informed consent document
  • Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel
  • Patients with a diagnosis of CTCL who have intractable pruritis
  • Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
  • Patients on chemo/immunotherapy with drug induced rash

Exclusion Criteria3

  • Patients currently undergoing radiotherapy
  • Patients currently receiving oral steroids
  • Patients who are unable to apply topical medications

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Interventions

DEVICEStrataCTX® gel

Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT04087629


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