CTCL
Conditions
Keywords
CTCL, topical steroids, StrataCTX®, cutaneous, steroid sparing
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.
Interventions
DEVICEStrataCTX® gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pruritus Visual Analogue Scale (VAS) Score | Screening through 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SKINDEX-16 Quality of Life (QOL) Score | Screening through 3 months | 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). |
| Change in the Rate of Primary Skin Reactions | Screening through 3 months | 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. |
| Change in Topical Steroid Use | Day 30 through 3 months | 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. |
Countries
United States
Contacts
CONTACTLarisa Geskin, MD
PRINCIPAL_INVESTIGATORLarisa J. Geskin, MD
Columbia University
Outcome results
None listed