StrataCTX® as a Steroid Sparing Device
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CTCL group Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel. |
Device: StrataCTX® gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
|
| Experimental: Skin Toxicity group Patients with skin toxicity secondary to chemo/immunotherapy will receive StrataCTX® gel. |
Device: StrataCTX® gel
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
|
Outcome Measures
Primary Outcome Measures
- 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) to 10 (worst imaginable itch)
Secondary Outcome Measures
- Change in SKINDEX-16 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.
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center, Department of Dermatology | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Larisa J Geskin, MD, Columbia University Department of Dermatology
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- AAAR6582