StrataCTX® as a Steroid Sparing Device

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04087629
Status
Recruiting
Apply to this trial

Conditions

  • CTCL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • StrataCTX® gel — DEVICE
    Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

Study Details

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.

Key Dates

Start date
Jul 7, 2021
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: CTCL group
    Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel.

Primary Outcome Measure

Change in Pruritus Visual Analogue Scale (VAS) Score [ Time Frame: Screening through 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Larisa Geskin, MD
[email protected]
Larisa J Geskin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center· New York, NY

Related Studies