Actively Recruiting
TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
Led by Tarian Pharma · Updated on 2025-02-10
60
Participants Needed
3
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies.
CONDITIONS
Official 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 to be treated with cetuximab or panitumumab injections
- Ability to understand and sign informed consent and comply with study protocol
- Ability to apply the study gel themselves or have a caregiver to apply it
- Predicted life expectancy greater than 3 months
- Willingness and ability to comply with all study time commitments and procedures
You will not qualify if you...
- History of EGFR inhibitor treatment in the past 2 years
- Any physical, psychological, or medical condition likely to prevent compliance with or completion of the study
- Uncontrolled or serious disease or medical/surgical condition posing significant risk
- History of other skin disorders (e.g., atopic dermatitis, psoriasis, recurrent skin infections) that may affect study results
- Significant skin disease other than EGFR inhibitor-induced folliculitis in treatment areas
- Presence of a beard interfering with study drug application or assessment
- Active infection in treatment or other body areas requiring systemic antibiotics
- Known or suspected allergies or sensitivities to any components of the study drugs
- Female patients who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Alexandra Lamquin, PhD
CONTACT
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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