Study on treatment of acneiform eruption by molecular target drug

JRCT ID: jRCTs021180037

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: acneiform eruption
• Date of first enrollment: 16/08/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Topical application of 2.5% benzoyl peroxide gel (Bepio gel) to acneiform eruption on the face due to EGFR inhibitors once daily for 8 weeks.

Outcome(s)

• Primary Outcome: Severity grade of acneiform eruption on the face

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tsuchiyama Kenichiro
• Source(s) of Monetary Support: Japan Agency for Medical and Development (AMED)
• Secondary ID(s): UMIN000032280