TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis
ConditionEGFR Inhibitor-associated Rash
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTarian Pharma
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Brimonidine tartrate Gel
DrugOnce daily applications for 7 days
Placebo gel (no Brimonidine tartrate)
DrugOnce daily applications for 7 days
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
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 preventive effectivness of TAR-0520 gel will be measured by assessing EGFR-induced folliculitis severity using a modified Common Terminology Criteria for Adverse Events (CTCAE) scale (Grade 0-no folliculitis - Grade 4-severe folliculitis)
Time frame
The measurements will be performed at Baseline visit and then at Day 14,Day 28,Day 42 and Day 56.Sponsors and contacts
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Source ClinicalTrials.gov