A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL) (CTCL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03292406 |
Recruitment Status :
Completed
First Posted : September 25, 2017
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cutaneous T Cell Lymphoma | Drug: Placebo Drug: CD11301 0.03% Drug: CD11301 0.06% | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 19, 2017 |
Actual Primary Completion Date : | March 17, 2020 |
Actual Study Completion Date : | March 17, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Placebo followed by CD11301 (0.03%) Topical Gel
|
Drug: Placebo
Non active ingredients of CD11301 Drug: CD11301 0.03% Topical Gel |
Experimental: Group 2
CD11301 (0.03%) Topical Gel
|
Drug: CD11301 0.03%
Topical Gel |
Experimental: Group 3
CD11301 (0.06%) Topical Gel
|
Drug: CD11301 0.06%
Topical Gel |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292406
United States, California | |
Galderma Investigational Site | |
Orange, California, United States, 92868 | |
Galderma Investigational Site | |
Palo Alto, California, United States, 94304 | |
United States, Connecticut | |
Galderma Investigational Site | |
Farmington, Connecticut, United States, 06032 | |
United States, Illinois | |
Galderma Investigational Site | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Galderma Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
United States, North Carolina | |
Galderma Investigational Site | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Galderma Investigational Site | |
Philadelphia, Pennsylvania, United States, 19104 | |
Galderma Investigational Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
Galderma Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Galderma Investigational Site | |
Dallas, Texas, United States, 75231 | |
Galderma Investigational Site | |
Houston, Texas, United States, 77030 | |
France | |
Galderma Investigational Site | |
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310 | |
Galderma Investigational Site | |
Nantes, Pays De La Loire, France, 44093 | |
Galderma Investigational Site | |
Paris, Île-de-France, France, 75010 | |
Germany | |
Galderma Investigational Site | |
Mannheim, Baden-Württemberg, Germany, 68167 | |
Galderma Investigational Site | |
Wurzburg, Bavaria, Germany, 97080 | |
Galderma Investigational Site | |
Krefeld, North Rhine-Westphalia, Germany, 47805 | |
Galderma Investigational Site | |
Minden, North Rhine-Westphalia, Germany, 32429 | |
Galderma Investigational Site | |
Münster, North Rhine-Westphalia, Germany, 48149 | |
Galderma Investigational Site | |
Kiel, Schleswig-Holstein, Germany, 24105 | |
Galderma Investigational Site | |
Berlin, Germany, 10117 |
Study Director: | Galderma R&D | Galderma R&D |
Responsible Party: | Galderma R&D |
ClinicalTrials.gov Identifier: | NCT03292406 |
Other Study ID Numbers: |
RD.03.SPR.104003 |
First Posted: | September 25, 2017 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No intent to share information. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
T-Cell Lymphoma Cutaneous CTCL |
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |