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Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma

NCT02301494 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-27

No results posted yet for this study

Summary

This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

Conditions

  • Mycosis Fungoides

Interventions

DRUG

3.75% Imiquimod Cream

CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.

DRUG

0.1% Fluocinonide Cream

CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Rochester Skin Lymphoma Medical Group, PLLC

    collaborator OTHER

  • Rochester General Hospital

    lead OTHER

Principal Investigators

  • Brian Poligone, M.D. Ph.D. · Rochester General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2022-04-30
Completion
2023-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301494 on ClinicalTrials.gov