Recruiting
Phase 1
Phase 2

Tazarotene

Sponsor:

McGill University

Code:

NCT00779896

Conditions

Cutaneous T-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tazarotene

Study Details

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.

Conditions

Cutaneous T-Cell Lymphoma

Study ID

NCT00779896

Start date

Oct, 2008

Status verified date

Oct, 2008

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Tazarotene

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

Primary 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 [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

David Roberge

514-934-1934david.roberge@muhc.mcgill.ca

Locations

McGill University

Recruiting

Montreal, Quebec, Canada, H2W 1S6

Contacts

Penny Chipman

514-398-1444penny.chipman@mcgill.ca

Crystal Lameira

514-398-2229crystal.lameira@mcgill.ca

More Information

Sponsor

McGill University

Last update posted

Oct 24, 2008

Last verified

Oct, 2008

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by McGill University on 2008-10-24.