Completed

NCT Number: NCT04239846

Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy

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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Key information

Conditions

EGFR Inhibitor-Induced Skin Rash

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taipei Veterans General Hospital, Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Is between 20 and 80 years of age, inclusive.
Patients who are within ±3 days of initiating EGFR inhibitor therapy using afatinib or erlotinib, and have no prior history of using afatinib or erlotinib within 6 months.
Has a life expectancy of at least three months.

Exclusion criteria

Has any active dermatological conditions of the face that may interfere with the diagnosis, assessment, or treatment of face skin rash associated with targeted cancer therapy.
Has been treated with steroids (systemic or topical on face) to the face within 7 days prior to Day 1.
Patients who have been treated with oral antibiotics that known to exert anti-inflammatory effect (such as doxycycline or minocycline) within 7 days prior to Day 1.
Is currently treated with target therapy other than afatinib or erlotinib.
Receive prior treatment with any investigational product within 28 days prior to Day 1.
Has hypersensitivity or allergy to the study medication.
Has any other significant diseases, conditions, or laboratory values which, in the opinion of the investigator, might make participation not in the subject's best interest or confound the interpretation of study results.

Treatment and study plan

AC-701 Topical Gel 0.3%

Drug

AC-701 Topical Gel 0.3%, BID

Other names: AC-701

Placebo gel

Other

Placebo Gel, BID

Other names: Placebo control

Primary outcomes

Number of subjects with MESTT Grade 0 or 1

Time frame: Week 4

Sponsors and collaborators

Lead sponsor

TWi Biotechnology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jan 27, 2020
Registry last updated: Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.