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Recruiting Phase 2

TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

NCT06818058 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2025-01-20
Last updated
2025-02-10

Condition(s) studied

EGFR Inhibitor-associated Rash

Investigational drug(s) / intervention(s)

Brimonidine tartrate GelPlacebo gel (no Brimonidine tartrate)

Brimonidine tartrate Gel: Once daily applications for 7 days

Placebo gel (no Brimonidine tartrate): Once daily applications for 7 days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • Frequency of Treatment - emergent Advers Events (TEAEs) — At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .
    TEAEs will be tabulated in frequency tables by System Organ Class and Preferred Term, based on the Medical Dictionary for Regulatory Activities (MedDRA). Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study drug, adverse events of special interest (AESIs), and AEs leading to discontinuation. The safety conclusions will be based on the comparative analysis of the AEs reported in the two treatment arms.

Trial sites (3)

FacilityCityRegionStatus
Hopital Privé Jean Mermoz Lyon France Recruiting
Institut Paoli Calmette Marseille France Recruiting
Centre Antoine Lacassagne Nice France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06818058 on ClinicalTrials.gov ↗ ← All trials in France