StrataCTX® as a Steroid Sparing Device

NCT04087629 | Recruiting DMC FDA Device

• 1 other identifier: AAAR6582
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CTCL

Keywords

CTCL; topical steroids; StrataCTX®; cutaneous; steroid sparing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in SKINDEX-16 Quality of Life (QOL) Score

  Screening through 3 months

• Change in the Rate of Primary Skin Reactions

  Screening through 3 months

• Change in Topical Steroid Use

  Day 30 through 3 months

Study Arms (1)

CTCL group

EXPERIMENTAL

Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel.

Device: StrataCTX® gel

Interventions

StrataCTX® gel DEVICE

Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

CTCL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients currently undergoing radiotherapy
• Patients currently receiving oral steroids
• Patients who are unable to apply topical medications

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Links

• StrataCTX Informational Pamphlet
• StrataCTX FAQS

Study Officials

• Larisa J. Geskin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larisa Geskin, MD

CONTACT

212-305-5293; ljg2145@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: September 12, 2019
• Study Start: July 7, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)