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Epidermal growth factor receptor inhibitor (EGFRI) therapy for cancer is associated with potentially severe face and trunk skin acneiform rash. Severe or persistent side effects may lead to decreased dose, interruption or discontinuation of EGFRI treatment. Inflammation is believed to play an important role in EGFRI-induced skin toxicity as a number of proinflammatory cytokines induced by EGFRI are released from epidermal cells, resulting in activation and recruitment of immune cells such as neutrophils and lymphocytes, and subsequent development of skin reaction associated with keratinocyte apoptosis. AC-701 has been reported its antibiotic and anti-inflammatory activities in literature, and further demonstrated in vitro effect to prevent the secretion of inflammatory cytokines associated with EGFR inhibition. This study is to evaluate the prophylactic efficacy of topical AC-701 in subjects with skin rash associated with EGFRI therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-701 | Experimental | AC-701 Topical Gel 0.3% |
|
| Placebo | Placebo Comparator | Placebo Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-701 Topical Gel 0.3% | Drug | AC-701 Topical Gel 0.3%, BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with MESTT Grade 0 or 1 | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Lin | TWi Biotechnology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan | ||||
| Chang Gung Memorial Hospital |
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| Placebo Gel | Other | Placebo Gel, BID |
|
|
| Taoyuan |
| Taiwan |