Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy

EGFR Inhibitor-Induced Skin Rash Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239846
• Other study ID #: AC-701-ONC-002
• Status: Completed
• Phase: Phase 2
• Start date: October 2, 2019
• Est. completion date: May 26, 2021

Study information

• Verified date: April 2022
• Source: TWi Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 26, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Is between 20 and 80 years of age, inclusive.

2. 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.

3. Has a life expectancy of at least three months.

Exclusion Criteria:

1. 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.

2. Has been treated with steroids (systemic or topical on face) to the face within 7 days prior to Day 1.

3. 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.

4. Is currently treated with target therapy other than afatinib or erlotinib.

5. Receive prior treatment with any investigational product within 28 days prior to Day 1.

6. Has hypersensitivity or allergy to the study medication.

7. 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.

Related Conditions & MeSH terms

• EGFR Inhibitor-Induced Skin Rash
• Exanthema

Intervention

Drug:
• AC-701 Topical Gel 0.3%
AC-701 Topical Gel 0.3%, BID

Other:
• Placebo Gel
Placebo Gel, BID

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
TWi Biotechnology, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with MESTT Grade 0 or 1		Week 4