TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis (NCT06818058) | Clinical Trial Compass
RecruitingPhase 2
TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
France60 participantsStarted 2025-01-20
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 giver who can apply the product
* 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
Exclusion Criteria:
* 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 ot…
What they're measuring
1
Frequency of Treatment - emergent Advers Events (TEAEs)
Timeframe: At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .