Status:
COMPLETED
A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Lead Sponsor:
Galderma R&D
Conditions:
Cutaneous T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03292406
Start Date
December 19 2017
End Date
March 17 2020
Last Update
April 8 2021
Active Locations (21)
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1
Galderma Investigational Site
Orange, California, United States, 92868
2
Galderma Investigational Site
Palo Alto, California, United States, 94304
3
Galderma Investigational Site
Farmington, Connecticut, United States, 06032
4
Galderma Investigational Site
Chicago, Illinois, United States, 60611