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

Information source: McGill University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cutaneous T-Cell Lymphoma

Intervention: Tazarotene (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: McGill University

Official(s) and/or principal investigator(s):
David Roberge, Principal Investigator, Affiliation: Montreal General Hospital

Overall contact:
David Roberge, Phone: 514-934-1934, Ext: 48080, Email: david.roberge@muhc.mcgill.ca

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

David Roberge, Phone: 514-934-1934, Ext: 48080, Email: david.roberge@muhc.mcgill.ca

McGill University, Montreal, Quebec H2W 1S6, Canada; Recruiting
Penny Chipman, Phone: 514-398-1444, Email: penny.chipman@mcgill.ca
Crystal Lameira, Phone: 514-398-2229, Email: crystal.lameira@mcgill.ca
Additional Information

Starting date: October 2008
Last updated: October 22, 2008

Page last updated: August 23, 2015

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