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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening through 3 months

Awards & highlights

Study Summary

This trial is testing if StrataCTX® can be used to treat skin reactions related to cancer treatments instead of the current standard treatment of topical steroids.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pruritus Visual Analogue Scale (VAS) Score

Secondary outcome measures

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

Change in Topical Steroid Use

Change in the Rate of Primary Skin Reactions

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,189 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size for this medical experiment?

"Affirmative. According to information from clinicaltrials.gov, this medical research is presently enrolling participants with the initial posting made on July 7th 2021 and updated most recently on August 3rd 2021. 70 volunteers are sought after between a sole location."

Answered by AI

Are there any still available positions within this clinical research endeavor?

"As per the information on clinicaltrials.gov, this particular study is actively looking for participants to join in. The medical trial was first advertised on July 7th 2021 and underwent its most recent update on August 3rd 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

StrataCTX® as a Steroid Sparing Device

Larisa Geskin, MD 2021. "StrataCTX® as a Steroid Sparing Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04087629.