Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash

Clalit Health Services

Status and phase: Completed; Phase 2

Conditions: Acneiform Rash

Treatments: Drug: ointment Synthomycine; Drug: Aqua cream; Drug: Threolone ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01256437

6046

Details and patient eligibility

About

The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Full description

The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

ointment Threolone

Experimental group

Description:

Treatment with topical application of combined anti inflammatory and anti bacterial agent.

Treatment:

Drug: Aqua cream

Drug: Threolone ointment

Drug: ointment Synthomycine

ointment Synthomycine

Active Comparator group

Description:

ointment once daily for 1 month

Treatment:

Drug: Aqua cream

Drug: ointment Synthomycine

Aqua cream

Placebo Comparator group

Treatment:

Drug: Aqua cream