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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032280
Receipt No. R000036732
Scientific Title An exploratory study on the usefulness of topical benzoxyl peroxide for prolonged acneiform eruption by EGFR inhibitors
Date of disclosure of the study information 2018/04/18
Last modified on 2018/12/13

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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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 15 Day
Last follow-up date
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
2018 Year 12 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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