A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
NCT ID: NCT03292406
Last Updated: 2021-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2017-12-19
2020-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CD11301 Gel 0.06%
Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
CD11301 0.06%
Topical Gel
CD11301 Gel 0.03%
Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.
CD11301 0.03%
Topical Gel
Placebo
Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.
Placebo
Non active ingredients of CD11301
CD11301 0.03%
Topical Gel
Interventions
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Placebo
Non active ingredients of CD11301
CD11301 0.03%
Topical Gel
CD11301 0.06%
Topical Gel
Eligibility Criteria
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Inclusion Criteria
* Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Galderma R&D
Role: STUDY_DIRECTOR
Galderma R&D
Locations
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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
Galderma Investigational Site
Houston, Texas, United States
Galderma Investigational Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Galderma Investigational Site
Nantes, Pays de la Loire Region, France
Galderma Investigational Site
Paris, Île-de-France Region, France
Galderma Investigational Site
Mannheim, Baden-Wurttemberg, Germany
Galderma Investigational Site
Würzburg, Bavaria, Germany
Galderma Investigational Site
Krefeld, North Rhine-Westphalia, Germany
Galderma Investigational Site
Minden, North Rhine-Westphalia, Germany
Galderma Investigational Site
Münster, North Rhine-Westphalia, Germany
Galderma Investigational Site
Kiel, Schleswig-Holstein, Germany
Galderma Investigational Site
Berlin, , Germany
Countries
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References
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Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD.03.SPR.104003
Identifier Type: -
Identifier Source: org_study_id
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