Trial Information
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Inclusion Criteria:
- Patients with Stage I-IIA CTCL must be at least 18 years of age with a skin biopsy
prior to enrolment confirming the diagnosis of mycosis fungoides.
Exclusion Criteria:
- Patients with Stage >IIA CTCL at the time of enrolment
- Women who are pregnant or planning to get pregnant, or unable/unwilling to use
adequate contraception
- Patients who were treated with topical retinoid therapy in the past 3 months
- Patients who received any systemic CTCL therapy or systemic corticosteroid therapy
within 30 days of the study start date
- Patients who were treated with systemic isotretinoin or bexarotene within 3 months
prior to the study start date, systemic acitretin within 2 years prior to study start
date
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Partial response (PR) is defined as some improvement (25%-50%);significant evidence of disease remains or disease has not changed from baseline condition (<25%);no new clinically abnormal(>1.5 cm)lymph nodes,<25% progression of existence
Outcome Time Frame:
unknown
Safety Issue:
Yes
Principal Investigator
David Roberge
Investigator Role:
Principal Investigator
Investigator Affiliation:
Montreal General Hospital
Authority:
Canada: Health Canada
Study ID:
McG 0722
NCT ID:
NCT00779896
Start Date:
October 2008
Completion Date:
December 2012
Related Keywords:
- Cutaneous T-cell Lymphoma
- To evaluate therapeutic potential of tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study
- Stage I-IIA disease CTCL
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous