StrataCTX® as a Steroid Sparing Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2026-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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CTCL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CTCL group

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

Group Type EXPERIMENTAL

StrataCTX® gel

Intervention Type DEVICE

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

Interventions

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StrataCTX® gel

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

Intervention Type DEVICE

Eligibility Criteria

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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