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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.
Select...
I cannot apply creams or ointments by myself.
Select...
I am currently receiving radiotherapy.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,482 Previous Clinical Trials
2,629,881 Total Patients Enrolled
Larisa J Geskin, MDPrincipal InvestigatorColumbia University Department of Dermatology
1 Previous Clinical Trials
Larisa J. Geskin, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

StrataCTX® gel (Steroid Sparing Device) Clinical Trial Eligibility Overview. Trial Name: NCT04087629 — N/A
Cutaneous T-Cell Lymphoma Research Study Groups: Skin Toxicity group, CTCL group
Cutaneous T-Cell Lymphoma Clinical Trial 2023: StrataCTX® gel Highlights & Side Effects. Trial Name: NCT04087629 — N/A
StrataCTX® gel (Steroid Sparing Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04087629 — N/A
~24 spots leftby Aug 2026