Acneiform Rash | Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash
Acneiform Rash research study
What is the primary objective of this study?
The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.
Who is eligible to participate?
Inclusion Criteria: - Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab. Exclusion Criteria: - Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation. - Known hypersensitivity to ointment Synthomycine or to Threolone. - Patients presented with cutaneous rash during the 2 weeks prior to study initiation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Threolone ointmentointment once daily for 1 month
Drug:ointment Synthomycineointment once daily for 1 month
Drug:Aqua creamointment once daily for 1 month
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ointment ThreoloneTreatment with topical application of combined anti inflammatory and anti bacterial agent.
ointment Synthomycineointment once daily for 1 month
Start Date: January 2011
Completed Date: March 2017
Phase: Phase 2
Primary Outcome: Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.
Secondary Outcome: Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms
Study sponsors, principal investigator, and references
Lead Sponsor: Rabin Medical Center
Lee JE, Lee SJ, Lee HJ, Lee JH, Lee KH. Severe acneiform eruption induced by cetuximab (Erbitux). Yonsei Med J. 2008 Oct 31;49(5):851-2. doi: 10.3349/ymj.2008.49.5.851.