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NCT Number: NCT04087629

StrataCTX® as a Steroid Sparing Device

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.

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Key information

Conditions

CTCL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Larisa Geskin, MD

CONTACT

[email protected]

Larisa J Geskin, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StrataCTX® gel

Device

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

Primary outcomes

  1. Change in Pruritus Visual Analogue Scale (VAS) Score

    Time frame: Screening through 3 months

    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).

Secondary outcomes

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

    Time frame: Screening through 3 months

    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).

  2. Change in the Rate of Primary Skin Reactions

    Time frame: Screening through 3 months

    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.

  3. Change in Topical Steroid Use

    Time frame: Day 30 through 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Larisa Geskin, MD

CONTACT

[email protected]

212-305-5293

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2019
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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