UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032280 |
|---|---|
| Receipt number | 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 | 2020/10/18 11:25:51 |
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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
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
kkikuchi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036732
