Using StrataCTX® to Reduce Steroid Use in CTCL Treatment
Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent
This study is testing if StrataCTX® can help adults with cutaneous T-cell lymphoma reduce their use of steroids while relieving skin reactions from cancer treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04087629 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of StrataCTX® as a steroid-sparing agent for patients with cutaneous T-cell lymphoma (CTCL) experiencing cutaneous reactions due to chemotherapy or immunotherapy. Participants will include adults diagnosed with CTCL who are currently using topical steroids or have developed skin reactions from cancer treatments. The study will assess whether StrataCTX® can provide relief from symptoms while minimizing the reliance on topical steroids, which are associated with various side effects. By comparing the outcomes of StrataCTX® with standard steroid treatments, the study seeks to identify a safer alternative for managing skin-related side effects in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of CTCL who are experiencing skin reactions and are currently reliant on topical steroids.
Not a fit: Patients currently undergoing radiotherapy or those receiving oral steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for topical steroids, thereby minimizing their associated side effects for patients with CTCL.
How similar studies have performed: While the use of StrataCTX® is a novel approach, similar studies exploring steroid-sparing strategies have shown promise in managing skin reactions in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients currently undergoing radiotherapy * Patients currently receiving oral steroids * Patients who are unable to apply topical medications
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Larisa J. Geskin, MD — Columbia University
- Study coordinator: Larisa Geskin, MD
- Email: ljg2145@cumc.columbia.edu
- Phone: 212-305-5293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.