UMIN-CTR Clinical Trial

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

acneiform eruption

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Severity grade of acneiform eruption on the face before and 8 weeks after the test treatment

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tohoku University Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

04

Month

17

Day

Last modified on

2020

Year

10

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036732