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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
Columbia University Irving Medical Center
New York, New York, United States
RECRUITINGChange 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).
Time frame: Screening through 3 months
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).
Time frame: Screening through 3 months
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.
Time frame: Screening through 3 months
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.
Time frame: Day 30 through 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.