Actively Recruiting
Post-marketing Surveillance of StrataCTX4 Flexible Wound Dressing as a Steroid Sparing Agent for Cutaneous T-cell Lymphoma and Chemotherapy/Immunotherapy-induced Skin Reactions
Led by Columbia University · Updated on 2025-10-02
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether StrataCTX4, a gel-forming flexible wound dressing, can serve as a steroid-sparing agent for treating skin reactions related to cutaneous T-cell lymphoma (CTCL) and chemotherapy or immunotherapy treatments. The study focuses on patients with CTCL who have skin reactions requiring topical steroids or those receiving chemotherapy/immunotherapy for other cancers who have developed skin reactions that warranted steroid use. It is important because topical steroids, the current standard, can cause many side effects, and effective alternatives are limited. Patients with CTCL treated with mechlorethamine gel will use StrataCTX4 gel during the study. This device is designed to prevent and treat radiation dermatitis and may help reduce the need for topical steroids. The study involves monitoring patients as they use the device, focusing on its potential to lessen steroid use and improve skin symptoms associated with cancer treatments. Participants will be assessed from screening through three months, with researchers measuring changes in itching using a visual scale, quality of life related to skin health, rates of primary skin reactions, and topical steroid use. The study does not involve blinding or placebo groups. Safety and effectiveness will be monitored over this period, and patients will continue their usual care alongside participation. The total duration of involvement for each participant is approximately three months.
CONDITIONS
Brief Title
StrataCTX® as a Steroid Sparing Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Ability to sign informed consent
- Diagnosis of cutaneous T-cell lymphoma (CTCL) with contact dermatitis to topical mechlorethamine gel
- Diagnosis of CTCL with intractable itching
- Reliance on topical steroids for symptom relief in CTCL
- Patients on chemotherapy or immunotherapy with drug-induced rash
You will not qualify if you...
- Currently undergoing radiotherapy
- Currently receiving oral steroids
- Unable to apply topical medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants with cutaneous T-cell lymphoma using mechlorethamine gel will apply StrataCTX® gel as a flexible wound dressing to prevent and treat skin reactions.
Regular visits during the 3 months to assess skin reactions and treatment effects
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
L
Larisa Geskin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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