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

Acneiform Rash Clinical Trial

— EGFR'I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256437
• Other study ID #: 6046
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2010
• Last updated: May 7, 2017
• Start date: January 2011
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acneiform Rash

Intervention

Drug:
• Threolone ointment
ointment once daily for 1 month
• ointment Synthomycine
ointment once daily for 1 month
• Aqua cream
ointment once daily for 1 month

Locations

Country	Name	City	State
Israel	Davidoff Center, Rabin Medical Center, Beilinson	Petach Tikva,

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Lacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms.		3 years
Secondary	Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms		3 years