Trial · NCT03292406
A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
NCT03292406, Phase 2, Completed, Galderma R&D; results first posted 2021-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL). Trials, record NCT03292406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292406
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
- NCT number
- NCT03292406
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 86 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Cutaneous T Cell Lymphoma
- Interventions
- Placebo, CD11301 0.03%, CD11301 0.06%
- First posted
- 2017-09-25
- Last updated
- 2021-04-08
- Results first posted
- 2021-04-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | Week 12 | Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion \>300 centimeter \[cm\]\^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline. |
| Secondary | Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | Week 12 | OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor). |
| Secondary | Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score | Up to Week 36 | Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion \>300 centimeter \[cm\]\^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. |
| Secondary | Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score | Up to Week 36 | The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion \>300 centimeter \[cm\]\^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. |
| Secondary | Time to Progressive Disease Using mSWAT | Up to Week 36 | Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response). |
| Secondary | Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36 | Week 12, 24 and Follow up (Week 36) | Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | Week 12 | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | Week 12 | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score | Up to Week 36 | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Days | NUMBER |
| SECONDARY | Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score | Up to Week 36 | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Days | NUMBER |
| SECONDARY | Time to Progressive Disease Using mSWAT | Up to Week 36 | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Days | NUMBER |
| SECONDARY | Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36 | Week 12, 24 and Follow up (Week 36) | ITT Population included all randomized participants. Here, overall number of participants analyzed signifies number of participants who were evaluable for this outcome measure and at specific category. | score on scale | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | CD11301 Gel 0.06% | Complete Response | 0 | Participants | |
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | CD11301 Gel 0.03% | Complete Response | 2 | Participants | |
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | Placebo | Complete Response | 0 | Participants | |
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | CD11301 Gel 0.06% | Partial Response | 4 | Participants | |
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | CD11301 Gel 0.03% | Partial Response | 5 | Participants | |
| Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12 | Placebo | Partial Response | 1 | Participants | |
| Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | CD11301 Gel 0.06% | Complete Response | 0 | Participants | |
| Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | CD11301 Gel 0.03% | Complete Response | 0 | Participants | |
| Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | Placebo | Complete Response | 0 | Participants | |
| Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 | CD11301 Gel 0.06% | Partial Response | 6 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CD11301 Gel 0.06% | 30 | |
| Overall Study | STARTED | CD11301 Gel 0.03% | 28 | |
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | Participants Treated | CD11301 Gel 0.06% | 30 | |
| Overall Study | Participants Treated | CD11301 Gel 0.03% | 28 | |
| Overall Study | Participants Treated | Placebo | 27 | |
| Overall Study | COMPLETED | CD11301 Gel 0.06% | 17 | |
| Overall Study | COMPLETED | CD11301 Gel 0.03% | 15 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | CD11301 Gel 0.06% | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events177
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CD11301 Gel 0.06% | 0 | 30 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | CD11301 Gel 0.03% | 0 | 28 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 27 | 2 |
| other | Bundle branch block left | Cardiac disorders | CD11301 Gel 0.06% | 2 | 30 | 2 |
| other | Bundle branch block left | Cardiac disorders | CD11301 Gel 0.03% | 0 | 28 | 0 |
| other | Bundle branch block left | Cardiac disorders | Placebo | 0 | 27 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | CD11301 Gel 0.06% | 0 | 30 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | CD11301 Gel 0.03% | 1 | 28 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo | 2 | 27 | 2 |
| other | Nausea | Gastrointestinal disorders | CD11301 Gel 0.06% | 4 | 30 | 5 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CD11301 Gel 0.06% | 0 | 30 |
| Total, all-cause mortality | CD11301 Gel 0.03% | 0 | 28 |
| Total, all-cause mortality | Placebo | 1 | 27 |
| Total, other adverse events | CD11301 Gel 0.06% | 30 | 30 |
| Total, other adverse events | CD11301 Gel 0.03% | 28 | 28 |
| Total, other adverse events | Placebo | 27 | 27 |
| Total, serious adverse events | CD11301 Gel 0.06% | 2 | 30 |
| Total, serious adverse events | CD11301 Gel 0.03% | 2 | 28 |
| Total, serious adverse events | Placebo | 1 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32632956 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03292406
GET https://conductscience.org/api/trials/v1/NCT03292406/results?page=2