StrataCTX® as a Steroid Sparing Device

Study Overview
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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.

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.

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

Conditions
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CTCL

Intervention / Treatment
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* Device: StrataCTX® gel


Participation Criteria
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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 Exclusion Criteria: Patients currently undergoing radiotherapy Patients currently receiving oral steroids Patients who are unable to apply topical medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTCL group<br>Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel. | Device: StrataCTX® gel<br>* Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis<br>|
| Experimental: Skin Toxicity group<br>Patients with skin toxicity secondary to chemo/immunotherapy will receive StrataCTX® gel. | Device: StrataCTX® gel<br>* Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SKINDEX-16 Quality of Life (QOL) Score | 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). | Screening through 3 months | 
| Change in the Rate of Primary Skin Reactions | 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. | Screening through 3 months | 
| Change in Topical Steroid Use | 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. | Day 30 through 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTCL, topical steroids, StrataCTX®, cutaneous, steroid sparing