Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy
Primary Purpose
EGFR Inhibitor-Induced Skin Rash
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
AC-701 Topical Gel 0.3%
Placebo Gel
Sponsored by
About this trial
This is an interventional prevention trial for EGFR Inhibitor-Induced Skin Rash
Eligibility Criteria
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.
Sites / Locations
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AC-701
Placebo
Arm Description
AC-701 Topical Gel 0.3%
Placebo Gel
Outcomes
Primary Outcome Measures
Number of subjects with MESTT Grade 0 or 1
Secondary Outcome Measures
Full Information
NCT ID
NCT04239846
First Posted
January 21, 2020
Last Updated
April 25, 2022
Sponsor
TWi Biotechnology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04239846
Brief Title
Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy
Official Title
A Randomized, Double-blind, Placebo-controlled Trial of AC-701 for Treatment of Skin Rash in Subjects With EGFR Inhibitor Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TWi Biotechnology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGFR Inhibitor-Induced Skin Rash
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AC-701
Arm Type
Experimental
Arm Description
AC-701 Topical Gel 0.3%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Gel
Intervention Type
Drug
Intervention Name(s)
AC-701 Topical Gel 0.3%
Other Intervention Name(s)
AC-701
Intervention Description
AC-701 Topical Gel 0.3%, BID
Intervention Type
Other
Intervention Name(s)
Placebo Gel
Other Intervention Name(s)
Placebo control
Intervention Description
Placebo Gel, BID
Primary Outcome Measure Information:
Title
Number of subjects with MESTT Grade 0 or 1
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Lin
Organizational Affiliation
TWi Biotechnology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy
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