StrataCTX® as a Steroid Sparing Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: StrataCTX® gel.
- Who it may be relevant to
- Registry conditions: CTCL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent
Overview
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
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.
Interventions
- Device StrataCTX® gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
Primary outcome measures
- Change in Pruritus Visual Analogue Scale (VAS) Score [Time frame: Screening through 3 months]
Secondary outcome measures (3)
- Change in SKINDEX-16 Quality of Life (QOL) Score [Time frame: Screening through 3 months]
- Change in the Rate of Primary Skin Reactions [Time frame: Screening through 3 months]
- Change in Topical Steroid Use [Time frame: Day 30 through 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT04087629 · AAAR6582