Recruiting

StrataCTX®

Sponsor:

Columbia University

Code:

NCT04087629

Conditions

CTCL

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

StrataCTX® gel

Study Details

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

Study ID

NCT04087629

Start date

Jul 7, 2021

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CTCL group

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

Interventions

StrataCTX® gel

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Larisa Geskin, MD

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

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Larisa Geskin, MD

ljg2145@cumc.columbia.edu

Principal Investigator:

Larisa J Geskin, MD

More Information

Sponsor

Columbia University

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Columbia University on 2025-10-02.