This trial studies how well StrataCTX works as a steroid sparing agent for patients with skin (cutaneous) reactions related to acute graft versus host disease (GVHD), cutaneous T cell lymphoma and chemotherapy/immunotherapy for solid/hematologic malignancies. StrataCTX is a full contact flexible wound dressing which may provide therapeutic relief including decreased itchiness and irritation, and provide relief from topical steroids which are known to thin the skin over time.
Additional locations may be listed on ClinicalTrials.gov for NCT04087629.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Contact: Larisa J. Geskin
Phone: 212-305-5293
PRIMARY OBJECTIVE:
I. To assess the use of silicone-based film forming topical gel (StrataCTX) as a steroid sparing agent for disorders usually treated with topical steroids.
SECONDARY OBJECTIVES:
I. To determine if StrataCTX will improve patient quality of life secondary to symptomatic improvement.
II. To determine if StrataCTX reduces complications, such as infection, caused by primary skin reactions.
III. To determine if StrataCTX reduces the severity of pruritus.
IV. To determine if StrataCTX reduces topical steroid requirement.
OUTLINE:
Patients taper their existing topical steroid regimen for 1 month then apply StrataCTX twice daily (BID) for 1 month. Patients may optionally continue StrataCTX for an additional 11 months.
After completion of study treatment, patients are followed up monthly for up to 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorLarisa J. Geskin