Interview study after treatment for skin cancer with Galderma gel CD11301 to capture information about treatment benefit as perceived by patient

Clinical Trial Exit Interview Study in Cutaneous T-cell Lymphoma (CTCL) to Capture Meaningful Treatment Benefit from a Patient’s Perspective

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001992-34-DE

Enrollment

Registered

2020-08-12

Start date

2020-10-29

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T Cell Lymphoma MedDRA version: 22.0 Level: LLT Classification code 10028483 Term: Mycosis fungoides System Organ Class: 100000004864

Interventions

Product Name: Resiquimod Product Code: CD11301 Pharmaceutical Form: Gel INN or Proposed INN: RESIQUIMOD CAS Number: 144875-48-9 Current Sponsor code: CD11301 Concentration unit: % percent Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Had participated or is currently participating in Galderma’s Phase 2 clinical trial of the CD11301 gel and has completed cycle 2 (week 24) or Patient has exited the study trial early due to patient request or clinician judgement 2. Able to remember experience with taking clinical trial treatment 3.Willing and able to participate in a 60-90 minute telephone interview 4.Able to understand, read, and speak native English (US) or German (Germany) sufficiently to participate in the interview 5. Willing and able to provide oral and written informed consent 6. Willing and consenting to be audio-recorded during the discussion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Hearing difficulty, visual impairment, acute psychopathology, or insufficient knowledge of English (US) or German (Germany) that, in the opinion of the investigator/interviewer, could interfere with patient ability to provide oral consent and written consent and complete an interview. 2. Not able to remember experience with taking clinical trial treatment in the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: Characterize patients’ experienced treatment benefit of CD11301 gel a.Provide a patient-focused assessment of disease burden. b.Capture patients’ experience of the study treatment (what are the perceived benefits and risks of treatment, changes in patients’ daily life since baseline, unexpected treatment effects, patients’ treatment expectations, satisfaction and comparison to previous treatments). c.Explore patients’ perceptions of meaningful change from baseline (i.e., what constitutes a meaningful treatment effect, which aspects are most relevant and most meaningful to patients). ;Secondary Objective: Explore patients’ experience with clinical trial participation and obtain patients’ insights into the operational aspects of the clinical trial (e.g., burden of visits, study procedures, etc.) to inform the design of future Phase 3 clinical trials with a view to increase their patient centricity. The telephone interview findings will also support the development of a comprehensive disease model to support a fit-for-purpose measurement strategy to assess meaningful treatment benefit of CD11301 gel in future clinical trials in CTCL. ;Primary end point(s): subject-reported concepts regarding disease burden and meaningful treatment benefit;Timepoint(s) of evaluation of this end point: after interview which takes place after patient has completed treatment	—

Measure

Time frame

Main Objective: Characterize patients’ experienced treatment benefit of CD11301 gel a.Provide a patient-focused assessment of disease burden. b.Capture patients’ experience of the study treatment (what are the perceived benefits and risks of treatment, changes in patients’ daily life since baseline, unexpected treatment effects, patients’ treatment expectations, satisfaction and comparison to previous treatments). c.Explore patients’ perceptions of meaningful change from baseline (i.e., what constitutes a meaningful treatment effect, which aspects are most relevant and most meaningful to patients). ;Secondary Objective: Explore patients’ experience with clinical trial participation and obtain patients’ insights into the operational aspects of the clinical trial (e.g., burden of visits, study procedures, etc.) to inform the design of future Phase 3 clinical trials with a view to increase their patient centricity. The telephone interview findings will also support the development of a comprehensive disease model to support a fit-for-purpose measurement strategy to assess meaningful treatment benefit of CD11301 gel in future clinical trials in CTCL. ;Primary end point(s): subject-reported concepts regarding disease burden and meaningful treatment benefit;Timepoint(s) of evaluation of this end point: after interview which takes place after patient has completed treatment

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Germany, United States

Contacts

Public ContactPrincipal Investigator

Evidera

Carla.dias-barbosa@evidera.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026