Topical gel for preventing skin rash in cancer patients
A Phase II Multicentric, Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis.
This study is testing a new gel to see if it can help prevent skin rashes in cancer patients who are receiving certain treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tarian Pharma Industry-sponsored |
| Drugs / interventions | cetuximab, panitumumab, chemotherapy, panitmumab |
| Locations | 3 sites (Lyon and 2 other locations) |
| Trial ID | NCT06818058 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial evaluates the safety and effectiveness of TAR-0520 gel in preventing folliculitis in patients with metastatic colorectal cancer receiving EGFR inhibitors like cetuximab or panitumumab. The study is multicentric, randomized, double-blind, and placebo-controlled, involving a treatment period of 7 days with daily applications of the gel. Participants will be monitored over four chemotherapy cycles to assess the gel's impact on the severity and extent of skin rash associated with their treatment. The goal is to provide a new preventive option for a common side effect of EGFR inhibitor therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic colorectal carcinoma who are scheduled to receive cetuximab or panitumumab.
Not a fit: Patients who have received EGFR treatment in the past two years or have conditions that may hinder compliance with the study protocol may not benefit.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of skin rashes in patients undergoing EGFR inhibitor therapy.
How similar studies have performed: While there is limited data on similar topical treatments for EGFR inhibitor-induced folliculitis, this approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon and 2 other locations
- Hopital Privé Jean Mermoz — Lyon, France (Recruiting)
- Institut Paoli Calmette — Marseille, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Janusz Czernielewski, MD
- Email: janusz.czernielewski@tarianpharma.com
- Phone: +33680338274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.