NCT03292406

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Placebo	Non active ingredients of CD11301
DRUG	CD11301 0.03%	Topical Gel
DRUG	CD11301 0.06%	Topical Gel

Timeline

• Start date: 2017-12-19
• Primary completion: 2020-03-17
• Completion: 2020-03-17
• First posted: 2017-09-25
• Last updated: 2021-04-08
• Results posted: 2021-04-08

Locations

21 sites across 3 countries: United States, France, Germany

Regulatory

• FDA-regulated drug study