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New treatment option for EGFR Inhibitor-associated Rash
Official title TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
ClinicalTrials.gov ID: NCT06818058
What this study is testing
What is Brimonidine tartrate Gel?
Brimonidine tartrate Gel is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for egfr inhibitor-associated rash.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- male or female, who is at least 18 years of age or older at the screening visit
- patients with clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the...
- patients who can understand and sign the Informed Consent Form, can communicate with investigator,can understand and comply with requierements of the...
- patients with predicted life expectency of \> 3 months
- patients willing and able to comply with all of the time commitements and procedural requirements of the clinical trial protocol
You likely can't join if
- patients with medical history of EGFR treatment in the past 2 years
- patients with any underlying physical ,psychological or medical condition that, in the opinion of the invstigator, would make it unlikely that the...
- patients with any uncotrolled or serious disease, or any medical or surgical condition,that may put the subject at significant risk (according to the...
- patients with history of other skin disorders (eg.atopic dermatitis,psoriasis,recurrent skin infections), or a history of illness that, in the...
- patients with significant skin disease other than EGFRi-induced folliculits within the same body areas planned for study drug application
- patients with a beard that would interfere with administration of the study drug and assessement of study endpoints
See the full eligibility criteria
- male or female, who is at least 18 years of age or older at the screening visit
- patients with clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol
- patients who can understand and sign the Informed Consent Form, can communicate with investigator,can understand and comply with requierements of the protocol, and can apply the study gel by himself/herself or have...
- patients with predicted life expectency of \> 3 months
- patients willing and able to comply with all of the time commitements and procedural requirements of the clinical trial protocol
- patients with medical history of EGFR treatment in the past 2 years
- patients with any underlying physical ,psychological or medical condition that, in the opinion of the invstigator, would make it unlikely that the patient will comply with the protocol or complete the study protocol
- patients with any uncotrolled or serious disease, or any medical or surgical condition,that may put the subject at significant risk (according to the investigator's judgement) if he/she participates in the clinical trial
- patients with history of other skin disorders (eg.atopic dermatitis,psoriasis,recurrent skin infections), or a history of illness that, in the opinion of the investigator, would confound the results of the study
- patients with significant skin disease other than EGFRi-induced folliculits within the same body areas planned for study drug application
- patients with a beard that would interfere with administration of the study drug and assessement of study endpoints
- patients with active infection within the treatment area ot in other body areas that requieres initiation of systemic antibiotics
- patients with known or suspected allergies or sensitivities to any components of the study drugs
- female patients who are pregnant or lactating
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Marseille, France
- Nice, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Marseille, France; Nice, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.