StrataCTX® as a Steroid Sparing Device

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.

Study Overview

• Status: Recruiting
• Conditions: CTCL
• Intervention / Treatment: Device: StrataCTX® gel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larisa Geskin, MD; Phone Number: 212-305-5293; Email: ljg2145@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Larisa Geskin, MD; Email: ljg2145@cumc.columbia.edu
      • Principal Investigator: Larisa J Geskin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTCL group; Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel.	Device: StrataCTX® gel; Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pruritus Visual Analogue Scale (VAS) Score	The primary objective of this study is to determine whether StrataCTX® gel is effective as a supportive therapy for cutaneous reactions treated with topical steroids as the standard of care. This objective will be measured by the Pruritus Visual Analogue Scale, which measures self-reported itching on a scale of 0 (no itching) (better outcome) to 10 (worst imaginable itch).	Screening through 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SKINDEX-16 Quality of Life (QOL) Score	Another objective is to determine if StrataCTX® will improve patient quality of life secondary to symptomatic improvement through the use of the Skindex 16 QOL (a dermatologic quality-of-life instrument) , which is a validated measure where participants self-report from 1 (never) - 5 (all the time) how each of 30 statements describes participants feelings related to their skin condition. All responses are transformed to a linear scale of 100, varying from 0 (no effect) (better outcome) to 100 (effect experienced all the time).	Screening through 3 months
Change in the Rate of Primary Skin Reactions	Change in the rate of primary skin reactions in participants between the topical steroid treatment period, compared to the StrataCTX® gel period as evaluated in screening visits.	Screening through 3 months
Change in Topical Steroid Use	Change in topical steroid use during the StrataCTX® gel period as reported daily in patient diaries with time, date, and location of topical steroid application.	Day 30 through 3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Larisa J. Geskin, MD, Columbia University

Publications and helpful links

Helpful Links

• StrataCTX Informational Pamphlet
• StrataCTX FAQS

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: CTCL; cutaneous; topical steroids; StrataCTX®; steroid sparing
• Other Study ID Numbers: AAAR6582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Clinical Endpoints/ individual patient data (IPD) will be assessed based on analysis of photos and evaluation of survey data, including scores from Pruritis VAS and Skindex-16 QOL scales. The scores during topical steroid treatment period will be compared to the scores during the StrataCTX® gel treatment period. Safety endpoints will be evaluated based on report of product related adverse events and subsequent study product interruption.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No