NCT04239846

Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy

A Randomized, Double-blind, Placebo-controlled Trial of AC-701 for Treatment of Skin Rash in Subjects With EGFR Inhibitor Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: TWi Biotechnology, Inc. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• EGFR Inhibitor-Induced Skin Rash

Interventions

Type	Name	Description
DRUG	AC-701 Topical Gel 0.3%	AC-701 Topical Gel 0.3%, BID
OTHER	Placebo Gel	Placebo Gel, BID

Timeline

• Start date: 2019-10-02
• Primary completion: 2021-05-12
• Completion: 2021-05-26
• First posted: 2020-01-27
• Last updated: 2022-04-27

Locations

2 sites across 1 country: Taiwan