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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Larisa Geskin, MD
ljg2145@cumc.columbia.edu
212-305-5293
Time Frame
Start Date: 2021-07-07
Estimated Completion Date: 2026-08
Participants
Target number of participants: 70
Treatments
Experimental: CTCL group
Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel.
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov