Study on treatment of acneiform eruption by molecular target drug

Phase 2

• Conditions: acneiform eruption

• Registration Number: JPRN-jRCTs021180037
• Lead Sponsor: Tsuchiyama Kenichiro

Brief Summary

Our findings suggest that topical BPO may be effective in treating prolonged AfE caused by EGFR inhibitors. The efficacy and safety of BPO treatment was confirmed by the improved grades of acneiform eruption severity, improved quality of life, and fewer side effects. Although, the frequency of irritation dermatitis and dry skin due to topical BPO was high, there was no problem with tolerability. As treatments for prolonged AfE have not yet been developed, randomized trials are needed to evaluate the effecti

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Study Completion: 2020-02-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

(1) Either patient who meet one of the following criteria ((a)(b)(c)).
(a) Patients who have non-small cell carcinoma and have received EGFR inhibitors (erlotinib, afatinib, gefitinib). EGFR inhibitors is scheduled to continue for more than 8 weeks.
(b) Patients who have colorectal cancer and have received EGFR inhibitors (cetuximab, panitumumab). EGFR inhibitors is scheduled to continue for more than 8 weeks.
(c) Patients who have head and neck cancer and have received EGFR inhibitors (cetuximab).EGFR inhibitors is scheduled to continue for more than 8 weeks.
(2) Patients, who diagnosed as acneiform eruption and received treatment of topical steroid with or without oral tetracycline, persist the eruption on the face even after 10 or more weeks after the start of EGFR inhibitors.
(3) ECOG performance status (PS) at the time of registration is 0 or 1.

Exclusion Criteria

(1) Oral tetracycline (MINO or DOXY) has been started within 4 weeks for the treatment of acneiform eruption.
(2) Oral steroids are administrated for the treatment of acneiform eruption.
(3) Patient has skin lesion of skin metastatic lesions, burns, frostbite, trauma, scars and/or other lesions to be difficult to evaluate skin symptoms on the test area.
(4) Patient has erosions, wounds, etc. that are problematic in applying benzoyl peroxide: BPO gel to the test area.
(5) Patient has a history of hypersensitivity to BPO.
(6) Pregnant women, women who has possibility of pregnant, woman within 28 days after childbirth, or woman who in breastfeeding.
(7) Patient who is considered to have difficulty participating in research by merging psychosis or psychiatric symptoms.
(8) Patient who researchers deem that research participation is inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity grade of acneiform eruption on the face

Secondary Outcome Measures

Name	Time	Method
(1) Severity Grade of acneiform eruption (CTCAE v.4.0)<br>(2) QOL questionnaire<br>(3) Skin adverse events due to topical steroid or BPO<br>(4) Skin toxicity assessment due to EGFR inhibitors<br>(5) Image analysis of acneiform eruption on the face by VISIA evolution (Tohoku University Hospital only)<br>(6) Bacterial culture from acneiform eruption