Prevention of EGFRI-induced folliculitis in colorectal cancer patients treated with ant-EGFR antibodies Skin and Connective Tissue Diseases
Conditions
Interventions
A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel-group study to confirm the good safety profile and to explore the preventative effect of topically applied TAR-0520 gel
Sponsors
Tarian Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, who is at least 18 years of age or older at the screening visit 2. Clinical diagnosis of metastatic colorectal carcinoma planned to be treated with cetuximab or panitumumab injections as part of the chemotherapy protocol 3. Patients who can understand and sign the Informed Consent Form, can communicate with the investigator, can understand and comply with the requirements of the protocol, and can apply the study gel by himself/herself or have a giver who can apply the products 4. Predicted life expectancy =3 months 5. Willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
Exclusion criteria
Exclusion criteria: 1. Patient with a medical history of EGFRi treatment in the past 2 years 2. Patient has any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the patient would comply with the protocol or complete the study per protocol. 3. Any uncontrolled or serious disease, or any medical or surgical condition, that may put the subject at significant risk (according to the Investigator’s judgment) if he/she participates in the clinical trial. 4. Patient has a 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 5. Significant skin disease other than EGFRI-induced acneiform lesions within the same body areas planned for study drug application 6. Has a beard that would interfere with administration of study drug and assessment of study endpoints 7. Active infection within the treatment area or in other body areas that requires initiation of systemic antibiotics 8. Known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator’s Brochure/Product label) 9. Female who is pregnant or lactating 10. Female who intends to conceive a child during the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety profile of TAR-0520 gel: the safety assessment will be conducted for all subjects at the screening visit (from the date of ICF signature) and at every subsequent visit. Any change in this assessment will trigger an AE report. The safety conclusions will thus be based on the comparative analysis of the AEs reported in the two treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| The preventive effectiveness of TAR-0520 gel will be measured using the modified Common Terminology Criteria for Adverse Events (CTCAE) scale, a Facial folliculitis severity score, and a patient assessment of severity (modified Functional Assessment of Cancer Therapy-EGFRI 18 [FACT-EGFRI 18]). The measurements will be performed at the baseline visit (D1-Visit 2) and then at D1 - Visits 3, 4, 5 and 6, just before the EGFRI-antibody intravenous infusion. | — |
Countries
France
Contacts
Public ContactJanusz;Emmanuel Czernielewski;Mitry
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Outcome results
None listed