What side effects are associated with this type of intervention?

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include topical steroids, which can cause side effects such as skin atrophy, telangiectasia, striae, and contact dermatitis. Long-term use may lead to systemic absorption, resulting in adrenal suppression, hyperglycemia, and Cushing's syndrome.

What prior FDA approvals exist?

The FDA has approved several treatments for Cutaneous T-Cell Lymphoma (CTCL), including topical and systemic therapies. Notable non-steroidal treatments include topical retinoids like bexarotene and systemic therapies such as vorinostat and romidepsin, which are histone deacetylase inhibitors. Additionally, the monoclonal antibody mogamulizumab and the fusion protein denileukin diftitox have been approved for CTCL. These treatments offer alternatives to traditional corticosteroid therapies, aligning with the goal of steroid-sparing strategies like those being studied with StrataCTX®.

What other types of research exist?

Promising novel alternatives to StrataCTX® for CTCL patients include: 1) Topical tacrolimus, a nonsteroidal calcineurin inhibitor, which has shown efficacy in treating cutaneous conditions. 2) Topical tazarotene, a third-generation retinoid, which has demonstrated improvement in skin conditions. 3) Anti-IL-17 therapies such as secukinumab and ixekizumab, which have shown efficacy in treating inflammatory skin diseases. These alternatives offer potential benefits and should be discussed with a healthcare provider.

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Steroid Sparing Device

StrataCTX® Gel for Skin Reactions from Cancer Treatment

N/A

Recruiting

Led By Larisa J Geskin, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Patients with a diagnosis of CTCL who have intractable pruritis

Must not have

Patients currently receiving oral steroids

Patients who are unable to apply topical medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening through 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing StrataCTX® to see if it can reduce the need for steroids in treating skin reactions in people with certain cancers. The goal is to find a safer alternative to steroids, which have many side effects. StrataCTX® might help manage these skin issues more effectively. StrataXRT® is a silicone-based gel used for preventing and managing skin problems caused by radiation.

Who is the study for?

This trial is for adults over 18 with Cutaneous T-Cell Lymphoma (CTCL) who use topical steroids for relief or have contact dermatitis from mechlorethamine gel. It's also open to those on chemo/immunotherapy with drug-induced rashes but not to patients on oral steroids or undergoing radiotherapy.

What is being tested?

The study tests if StrataCTX® gel can replace topical steroids in treating skin reactions from CTCL and cancer treatments. Participants will use the gel instead of their usual steroid creams to see if it's more effective or has fewer side effects.

What are the potential side effects?

Potential side effects are not detailed, but as a topical agent, StrataCTX® may cause local skin irritation, redness, itching, or allergic reactions similar to other skin-applied medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have CTCL and suffer from severe itching.

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I have CTCL and am allergic to mechlorethamine gel.

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I am experiencing a rash from my cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking oral steroids.

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I cannot apply creams or ointments by myself.

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I am currently receiving radiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening through 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening through 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pruritus Visual Analogue Scale (VAS) Score

Secondary study objectives

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

Change in Topical Steroid Use

Change in the Rate of Primary Skin Reactions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Skin Toxicity groupExperimental Treatment1 Intervention

Patients with skin toxicity secondary to chemo/immunotherapy will receive StrataCTX® gel.

Group II: CTCL groupExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Cutaneous T-Cell Lymphoma (CTCL) include topical steroids and steroid-sparing agents. Topical steroids reduce inflammation and suppress the immune response in the skin, helping to control CTCL symptoms. Steroid-sparing agents, like StrataCTX®, aim to provide similar anti-inflammatory effects without the long-term side effects of steroids, such as skin atrophy and systemic complications. This approach is crucial for CTCL patients as it allows effective disease management while minimizing adverse effects.