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Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study

Phase 1
Conditions
Cutaneous T-Cell Lymphoma
Registration Number
NCT00779896
Lead Sponsor
McGill University
Brief Summary

This is an open label, prospective study 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. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
15
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

McGill University

🇨🇦

Montreal, Quebec, Canada

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