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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?

Acneiform Rash

Study Interventions

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

Study Arms

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

Aqua cream

Study Status

Completed

Start Date: January 2011

Completed Date: March 2017

Phase: Phase 2

Type: Interventional

Design:

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

Principal Investigator:

Lead Sponsor: Rabin Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01256437

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.

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