Actively Recruiting
A Phase II Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel for EGFR Inhibitor-induced Folliculitis in Metastatic Colorectal Cancer Patients
Led by Tarian Pharma · Updated on 2025-02-10
60
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of TAR-0520 gel to prevent and treat folliculitis caused by EGFR inhibitor drugs in patients with metastatic colorectal cancer. These skin side effects commonly appear within 1 to 2 weeks of treatment with cetuximab or panitumumab and affect areas like the face, upper torso, and scalp. This Phase II trial aims to confirm the safety of TAR-0520 gel and explore its effect on reducing the extent and severity of this folliculitis. Participants will be randomly assigned to receive either the active TAR-0520 gel containing brimonidine tartrate or a placebo gel without it. They will apply the gel once daily for 7 days during each chemotherapy cycle, followed by a treatment-free period until the next cycle starts. The study covers 4 chemotherapy cycles, lasting at least 56 days. During the trial, researchers will monitor safety by measuring treatment-emergent adverse events at baseline and on days 14, 28, 42, and 56. They will also assess how well TAR-0520 gel prevents folliculitis at these same time points. Participants will be expected to apply the gel themselves or have a caregiver assist, and they will be evaluated regularly throughout the study period.
CONDITIONS
Brief Title
TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Clinical diagnosis of metastatic colorectal carcinoma planned for treatment with cetuximab or panitumumab injections
- Able to understand and sign informed consent, communicate with investigators, and comply with study requirements
- Able to apply the study gel themselves or have a caregiver who can apply it
- Predicted life expectancy greater than 3 months
- Willing and able to comply with all time commitments and procedures of the trial
You will not qualify if you...
- Received EGFR treatment within the past 2 years
- Any physical, psychological, or medical condition that may prevent compliance with the study protocol
- Any uncontrolled or serious disease or medical/surgical condition posing significant risk according to investigator judgment
- History of other skin disorders such as atopic dermatitis, psoriasis, or recurrent skin infections
- Significant skin disease other than EGFR inhibitor-induced folliculitis in the treatment areas
- Presence of a beard interfering with gel application and study assessments
- Active infection in treatment area or elsewhere requiring systemic antibiotics
- Known or suspected allergies or sensitivities to study drug components
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 chemotherapy cycles lasting at least 56 days
Participants apply the study gel once daily for 7 days during each chemotherapy cycle to prevent EGFR inhibitor-induced folliculitis.
1 visit per chemotherapy cycle for assessments, approximately 5 visits total
Trial Site Locations
Total: 3 locations
1
Hopital Privé Jean Mermoz
Lyon, France, 69008
Actively Recruiting
2
Institut Paoli Calmette
Marseille, France, 13273
Actively Recruiting
3
Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
Research Team
J
Janusz Czernielewski, MD
A
Alexandra Lamquin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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