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A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA

NCT03292406•Galderma R&D

View on ClinicalTrials.gov

Summary

To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).

Detailed Description

To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months
•Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions

Exclusion Criteria

•CTCL that is stage IIB or great or stage IIA with stage N2 with \>5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL
•History of autoimmune disease
•Laboratory test values at screening outside of the normal range and judged clinically significant by the investigator
•Current participation in another clinical trial of a drug or device or past participation within 4 weeks before Baseline or participant is in exclusion period from a previous clinical trial

Locations (21)

Galderma Investigational Site

Orange, California, United States

Galderma Investigational Site

Palo Alto, California, United States

Galderma Investigational Site

Farmington, Connecticut, United States

Galderma Investigational Site

Chicago, Illinois, United States

Galderma Investigational Site

Boston, Massachusetts, United States

Galderma Investigational Site

Durham, North Carolina, United States

Galderma Investigational Site

Philadelphia, Pennsylvania, United States

Galderma Investigational Site

Philadelphia, Pennsylvania, United States

Galderma Investigational Site

Pittsburgh, Pennsylvania, United States

Galderma Investigational Site

Dallas, Texas, United States

Key Dates

Start Date

December 19, 2017

Primary Completion Date

March 17, 2020

Completion Date

March 17, 2020

Last Updated

April 8, 2021

Enrollment

ACTUAL participants

Conditions

Cutaneous T Cell Lymphoma

Interventions

Placebo

DRUG

CD11301 0.03%

DRUG

CD11301 0.06%

DRUG

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

NCT07356245

T-cell LymphomaGraft Versus Host Disease+6 more

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RECRUITING

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

NCT06588868

Cutaneous T Cell LymphomaCutaneous T-Cell Lymphoma/Mycosis Fungoides+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Inclusion Criteria

Exclusion Criteria

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Photopheresis in Early-stage Mycosis Fungoides

Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL

Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment