A Phase 2 interventional study of AC-701 Topical Gel 0.3% and Placebo Gel in EGFR Inhibitor-Induced Skin Rash, sponsored by TWi Biotechnology, Inc.. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by TWi Biotechnology, Inc. · Phase 2, Interventional, and Prevention
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.
68 studies on the registry are indexed under Exanthema; 11 are open to participants now.
This study's enrollment of 74 is above the median of 60 across 45 interventional studies indexed under Exanthema.
Browse Exanthema studies →TWi Biotechnology, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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AC-701 Topical Gel 0.3%
Drug: AC-701 Topical Gel 0.3%
Placebo Gel
Other: Placebo Gel
AC-701 Topical Gel 0.3%, BID
Also known as: AC-701
Placebo Gel, BID
Also known as: Placebo control
Number of subjects with MESTT Grade 0 or 1
Time frame: Week 4
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in May 2021, 19 months.
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TWi Biotechnology, Inc.