Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash (EGFR'I)
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ClinicalTrials.gov Identifier: NCT01256437 |
Recruitment Status
:
Completed
First Posted
: December 8, 2010
Last Update Posted
: May 9, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acneiform Rash | Drug: Threolone ointment Drug: ointment Synthomycine Drug: Aqua cream | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: ointment Threolone
Treatment with topical application of combined anti inflammatory and anti bacterial agent.
|
Drug: Threolone ointment
ointment once daily for 1 month
Drug: ointment Synthomycine
ointment once daily for 1 month
Drug: Aqua cream
ointment once daily for 1 month
|
Active Comparator: ointment Synthomycine
ointment once daily for 1 month
|
Drug: ointment Synthomycine
ointment once daily for 1 month
Drug: Aqua cream
ointment once daily for 1 month
|
Placebo Comparator: Aqua cream |
Drug: Aqua cream
ointment once daily for 1 month
|
- Number of patients developing grade 2 / above rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms. [ Time Frame: 3 years ]
- Number of patients developing a rash under preventative treatment with ointment threolone, compared to the other 2 treatment arms [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256437
Israel | |
Davidoff Center, Rabin Medical Center, Beilinson | |
Petach Tikva,, Israel, 49100 |
Publications:
Responsible Party: | iris amitay, Iris Amitay-Laish, MD, Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT01256437 History of Changes |
Other Study ID Numbers: |
6046 |
First Posted: | December 8, 2010 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Keywords provided by iris amitay, Rabin Medical Center:
Acneiform eruption papulopustular EGFR cetuximab |
erlotinib gefitinib panitumumab eruption secondary to treatment with either cetuximab |
Additional relevant MeSH terms:
Cetuximab Antineoplastic Agents |