Clinical trial NCT04087629: StrataCTX® As a Steroid Sparing Device
Official title: Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use As a Steroid Sparing Agent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CTCL
Keywords: CTCL
topical steroids
StrataCTX®
cutaneous
steroid sparing
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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

Primary outcomes:
measure: Change in Pruritus Visual Analogue Scale (VAS) Score
timeFrame: Screening through 3 months
Secondary outcomes:
measure: Change in SKINDEX-16 Quality of Life (QOL) Score
timeFrame: Screening through 3 months
measure: Change in the Rate of Primary Skin Reactions
timeFrame: Screening through 3 months
measure: Change in Topical Steroid Use
timeFrame: Day 30 through 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Larisa J. Geskin, MD
role: PRINCIPAL_INVESTIGATOR
References: