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Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent
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.
Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Columbia University Irving Medical Center
New York, New York, United States
Start Date
July 7, 2021
Primary Completion Date
August 1, 2026
Completion Date
August 1, 2026
Last Updated
October 2, 2025
70
ESTIMATED participants
StrataCTX® gel
DEVICE
Lead Sponsor
Columbia University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06925464