StrataCTX® As a Steroid Sparing Device

Last updated: September 27, 2024
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cutaneous T-cell Lymphoma

Treatment

StrataCTX® gel

Clinical Study ID

NCT04087629
AAAR6582
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Ability to sign informed consent document

  • Patient with a diagnosis of CTCL who have contact dermatitis to topicalmechlorethamine gel

  • Patients with a diagnosis of CTCL who have intractable pruritis

  • Patients with a diagnosis of CTCL who rely heavily on topical steroids forsymptomatic relief

  • Patients on chemo/immunotherapy with drug induced rash

Exclusion

Exclusion Criteria:

  • Patients currently undergoing radiotherapy

  • Patients currently receiving oral steroids

  • Patients who are unable to apply topical medications

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: StrataCTX® gel
Phase:
Study Start date:
July 07, 2021
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Medical Center, Department of Dermatology

    New York, New York 10032
    United States

    Active - Recruiting

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