UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055784 |
|---|---|
| Receipt number | R000063556 |
| Scientific Title | Randomized controlled trial of tetracycline antibiotics (minocycline vs doxycycline) in preventing skin disorders caused by epidermal growth factor receptor (EGFR) inhibitors. |
| Date of disclosure of the study information | 2024/10/09 |
| Last modified on | 2025/10/10 14:35:37 |
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Basic information
Public title
Randomized controlled trial of tetracycline antibiotics (minocycline vs doxycycline) in preventing skin disorders caused by epidermal growth factor receptor (EGFR) inhibitors.
Acronym
Randomized controlled trial of tetracycline antibiotics (minocycline vs doxycycline) in preventing skin disorders caused by epidermal growth factor receptor (EGFR) inhibitors.
Scientific Title
Randomized controlled trial of tetracycline antibiotics (minocycline vs doxycycline) in preventing skin disorders caused by epidermal growth factor receptor (EGFR) inhibitors.
Scientific Title:Acronym
Randomized controlled trial of tetracycline antibiotics (minocycline vs doxycycline) in preventing skin disorders caused by epidermal growth factor receptor (EGFR) inhibitors.
Region
| Japan |
Condition
Condition
colorectal cancer,lung cancer
Classification by specialty
| Gastrointestinal surgery | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
As there are no reports directly comparing the preventive effects of doxycycline vs minocycline on acneiform rash caused by EGFR inhibitors, we will conduct a comparative study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Incidence rate of grade 2 (CTCAE v5.0) or higher rash acneiform within 12 weeks after starting EGFR molecular targeting drug administration.
Key secondary outcomes
Period until first appearance of rash acneiform by grade
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Orally administer minocycline at 100 mg/day.
Interventions/Control_2
Orally administer doxycycline at 100 mg/day.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients receiving treatment at Saiseikai Yamaguchi General Hospital.
2.Patients who were administered panitumumab, cetuximab, afatinib, erlotinib, osimertinib or amivantamab for the first time or after a period of time had passed and skin disorders had disappeared.
3.Have signed written informed consent to participate in this study.
Key exclusion criteria
1.Patients who could not continue treatment by the 12th week.
2.Patients who have developed skin disorders other than rash acneiform specific to EGFR inhibitors, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS).
3.Patients under 18 years of age.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Nishi |
Organization
Saiseikai Yamaguchi General Hospital
Division name
Department of Pharmacy
Zip code
753-0078
Address
2-11 Midoricho, Yamaguchi City, Yamaguchi Prefecture
TEL
0839016111
yakuzai-di@ymg-saiseikai.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Nishi |
Organization
Saiseikai Yamaguchi General Hospital
Division name
Department of Pharmacy
Zip code
753-0078
Address
2-11 Midoricho, Yamaguchi City, Yamaguchi Prefecture
TEL
0839016111
Homepage URL
yakuzai-di@ymg-saiseikai.jp
Sponsor or person
Institute
Saiseikai Yamaguchi General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee
Address
2-11 Midoricho, Yamaguchi City, Yamaguchi Prefecture
Tel
0839016111
yakuzai-di@ymg-saiseikai.jp
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
| 2024 | Year | 10 | Month | 09 | 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
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063556
