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

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ClinicalTrials.gov Identifier: NCT03292406
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

September 15, 2017
September 25, 2017
October 16, 2018
December 19, 2017
August 2019   (Final data collection date for primary outcome measure)
Overall response rate of target lesions at Week 12 based on CAILS score. [ Time Frame: Week 12 ]
Overall response rate (Complete and Partial Response) of target lesions based on the Composite Assessment of Index Lesion Severity (CAILS) score.
Same as current
Complete list of historical versions of study NCT03292406 on ClinicalTrials.gov Archive Site
Overall response rate based upon mSWAT composite score at Week 12. [ Time Frame: Week 12 ]
Overall response rate (Complete and Partial Response) based upon mSWAT composite score.
Same as current
Not Provided
Not Provided
 
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
To assess the efficacy, safety and pharmacokinetics in subjects treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Cutaneous T Cell Lymphoma
  • Drug: Placebo
    Non active ingredients of CD11301
  • Drug: CD11301 0.03%
    Topical Gel
  • Drug: CD11301 0.06%
    Topical Gel
  • Experimental: Group 1
    Placebo followed by CD11301 (0.03%) Topical Gel
    Interventions:
    • Drug: Placebo
    • Drug: CD11301 0.03%
  • Experimental: Group 2
    CD11301 (0.03%) Topical Gel
    Intervention: Drug: CD11301 0.03%
  • Experimental: Group 3
    CD11301 (0.06%) Topical Gel
    Intervention: Drug: CD11301 0.06%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
Same as current
August 2019
August 2019   (Final data collection date for primary outcome measure)

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 subject is in exclusion period from a previous clinical trial
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Galderma R&D 817-961-5120 frnceclinicaltrials@galderma.com
France,   Germany,   United States
 
 
NCT03292406
RD.03.SPR.104003
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: No intent to share information.
Galderma R&D
Galderma R&D
Not Provided
Study Director: Galderma R&D Galderma R&D
Galderma R&D
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP