UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study on the usefulness of topical benzoxyl peroxide for prolonged acneiform eruption by EGFR inhibitors
Acronym	Study on the usefulness of topical benzoyl peroxide for acneiform eruption by EGFR inhibitors
Scientific Title	An exploratory study on the usefulness of topical benzoxyl peroxide for prolonged acneiform eruption by EGFR inhibitors
Scientific Title:Acronym	Study on the usefulness of topical benzoyl peroxide for acneiform eruption by EGFR inhibitors
Region	Japan

Condition
Condition	acneiform eruption
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of topical benzoyl peroxide (BPO) to EGFR inhibitors-induced acneiform eruption, which are prolonged and resistant to treat by topical steroid and oral tetracycline antibiotics.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Severity grade of acneiform eruption on the face before and 8 weeks after the test treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment: topical benzoyl peroxide once daily to acneiform eruption for 8 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	79 years-old >=
Gender	Male and Female
Key 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 pr 1.
Key exclusion criteria	(1)Oral tetracycle (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.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuko Kikuchi
Organization	Tohoku University Hospital
Division name	Dermatology
Zip code
Address	1-1 Seryo-machi, Aoba-ku, Sendai
TEL	022-717-7271
Email	kkikuchi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Katsuko Kikuchi
Organization	Tohoku University Hospital
Division name	Dermatology
Zip code
Address	1-1 Seryo-machi, Aoba-ku, Sendai
TEL	022-717-7271
Homepage URL
Email	kkikuchi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 27 Day
Date of IRB	2018 Year 05 Month 07 Day
Anticipated trial start date	2018 Year 04 Month 15 Day
Last follow-up date	2020 Year 05 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 17 Day
Last modified on	2020 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036732