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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

About this trial

This is an interventional prevention trial for EGFR Inhibitor-Induced Skin Rash

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy

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