StrataCTX® as a Steroid Sparing Device

CTCL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087629
• Other study ID #: AAAR6582
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Larisa Geskin, MD
• Phone: 212-305-5293
• Email: ljg2145[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CTCL

Intervention

Device:
• StrataCTX® gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   StrataCTX FAQS
•   StrataCTX Informational Pamphlet