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Brief Title: Safety, Tolerability and Efficacy Study of Doxycycline Foam for the Prevention of EGFRI Skin Toxicity in Cancer Patients
Official Title: A Safety, Tolerability and Efficacy Study of Doxycycline Topical Foam Administered Topically for Prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects With Cancer Receiving Cetuximab or Panitumumab
Study ID: NCT02239731
Brief Summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of FDX104 Antibiotic Foam in the prevention of EGFRI skin toxicity in cancer patients receiving Cetuximab or Panitumumab.
Detailed Description: This is a phase II multicenter, randomized, double blind, vehicle controlled clinical study to evaluate the safety, tolerability and efficacy of Doxycycline Foam 4% for the prevention of Epidermal Growth Factor Receptor Inhibition Skin Toxicity, to Subjects with Cancer Receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis. The study consists of a screening visit, a treatment period where patients will be treated topically on the face twice daily for 5 weeks. A post-treatment follow up visit (4 weeks after end of treatment), will be performed only for subjects who have experienced unresolved possibly-related or related adverse events at the end of the treatment. Seven days after randomization and study drug initiation, subjects will start their EGFRI treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Soroka Medical Center, Be'er-Sheva, , Israel
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petah-Tikva, , Israel
Assaf Harofeh medical center, Rishon LeZion, , Israel
Sourasky medical center, Tel Aviv, , Israel
Sheba medical center, Tel Hashomer, , Israel
Name: Ravit Geva, MD
Affiliation: Sourasky Medical center, Tel-aviv, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: Einat Shacham Shmueli, MD
Affiliation: Sheba Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Nirit Yarom, MD
Affiliation: Assaf Harofeh medical center, Beer Yaakov, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: Valerya Semenysty, MD
Affiliation: Rambam Health Care Campus
Role: PRINCIPAL_INVESTIGATOR
Name: Ayala Hubert, MD
Affiliation: Hadassah Medical Organization
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander Gluzman, MD
Affiliation: Soroka University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Hadas Prag Nave, MD
Affiliation: Rabin Medical Center
Role: PRINCIPAL_INVESTIGATOR