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

Double Blind Placebo Controlled Trial, for Evaluating Preventive Therapy With Either Oint Threolone Versus Synthomycine Versus Aqua Cream, for EGFR'I Induced Acneiform Rash

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01256437
Acronym
EGFR'I
Enrollment
90
Registered
2010-12-08
Start date
2011-01-31
Completion date
2017-03-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acneiform Rash

Keywords

Acneiform eruption, papulopustular, EGFR, cetuximab, erlotinib, gefitinib, panitumumab, eruption secondary to treatment with either cetuximab

Brief summary

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

Detailed description

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

Interventions

DRUGThreolone ointment

ointment once daily for 1 month

DRUGointment Synthomycine

ointment once daily for 1 month

DRUGAqua cream

ointment once daily for 1 month

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.3 years

Secondary

MeasureTime frame
Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms3 years

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026