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

NCT ID: NCT00779896

Last Updated: 2008-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Cutaneous T-Cell Lymphoma

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tazarotene

Topical 0.1 cream - apply to lesions on alternate days and at 2 week interval increase to once-daily application, if tolerated.

Intervention Type DRUG

Other Intervention Names

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Tazorac (trademark name) Tazarotenic Acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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McGill University

Principal Investigators

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David Roberge

Role: PRINCIPAL_INVESTIGATOR

Montreal General Hospital

Locations

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McGill University

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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David Roberge

Role: CONTACT

Phone: 514-934-1934

Email: [email protected]

Facility Contacts

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Penny Chipman

Role: primary

Crystal Lameira

Role: backup

Other Identifiers

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McG 0722

Identifier Type: -

Identifier Source: org_study_id