TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis

NCT06818058 | Recruiting Phase 2

• 2 other identifiers: TARIAN 0072024-516339-28-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

EGFR Inhibitor-associated Rash

Keywords

EGFR inhibitor-induced skin rash;; EGFR inhibitor-induced folliculitis

Outcome Measures

Primary Outcomes (1)

• Frequency of Treatment - emergent Advers Events (TEAEs)

  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.

  At Baseline and then at Day 14, Day 28, Day 42 and Day 56 .

Secondary Outcomes (1)

• Efficacy of TAR-0520 gel to prevent EGFR-induced folliculits

  The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.

Study Arms (2)

Active arm

EXPERIMENTAL

Brimonidine tartrate gel

Drug: Brimonidine tartrate Gel

Placebo arm

PLACEBO COMPARATOR

Drug: Placebo gel (no Brimonidine tartrate)

Interventions

Brimonidine tartrate Gel DRUG

Once daily applications for 7 days

Active arm

Placebo gel (no Brimonidine tartrate) DRUG

Once daily applications for 7 days

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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

Sponsors & Collaborators

• Tarian Pharma: lead

Study Sites (3)

Hopital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

Institut Paoli Calmette

Marseille, 13273, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

NOT YET RECRUITING

Central Study Contacts

Janusz Czernielewski, MD

CONTACT

+33680338274; janusz.czernielewski@tarianpharma.com

Alexandra Lamquin, PhD

CONTACT

alexandra.lamquin@tarianpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 10, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)