UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017148 |
|---|---|
| Receipt number | R000019892 |
| Scientific Title | An open randomized controlled study of topical B blocker gel for the treatment of infantile hemangioma: Comparison of safety and efficacy among topical 0%, 1% 5% B blocker gel. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2019/07/31 11:50:04 |
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Basic information
Public title
An open randomized controlled study of topical B blocker gel for the treatment of infantile hemangioma: Comparison of safety and efficacy among topical 0%, 1% 5% B blocker gel.
Acronym
A controlled study of B blocker gel for the treatment of infantile hemangioma
Scientific Title
An open randomized controlled study of topical B blocker gel for the treatment of infantile hemangioma: Comparison of safety and efficacy among topical 0%, 1% 5% B blocker gel.
Scientific Title:Acronym
A controlled study of B blocker gel for the treatment of infantile hemangioma
Region
| Japan |
Condition
Condition
Infantile hemangioma
Classification by specialty
| Pediatrics | Dermatology | Plastic surgery |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the short-term efficacy and safety of the treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
color of tumor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Small amount of 0% B blockre gel is applied to tumor two times a day for 6 months.
Interventions/Control_2
Small amount of 1% B blockre gel is applied to tumor two times a day for 6 months.
Interventions/Control_3
Small amount of 5% B blockre gel is applied to tumor two times a day for 6 months.
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
| 2 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
two types of infantile hemangioma (superficial type, mixed type which is both superficial and deep)
Key exclusion criteria
Patients who have asthma, cardiovascular malformation, diabetes, medication (including adrenaline, beta-blocker, calcium antagonist agent, digitalis product, CYP2D6 inhibitor), other skin disease, many infant hemangioma, congenital hemangioma.
Patients who are ruled unfit to this study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Mitsukawa |
Organization
Chiba university hospital
Division name
Dept. of plastic reconstructive, and aesthetic surgery
Zip code
260-8677
Address
Inohana 1-8-1, Chuo-ku, Chiba city
TEL
043-226-2316
kane.satoh@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Naoaki |
| Middle name | |
| Last name | Rikihisa |
Organization
Chiba rosai hospital
Division name
plastic surgery
Zip code
260-8677
Address
Tastumidai-higashi 2-16, Ishihara City
TEL
0436-74-1111
Homepage URL
rikihisa@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba rosai hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba rosai hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Clinical Research Center
Address
1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Tel
043-222-7171
chibacrc@mac.com
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
千葉大学病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
19
Results
In the PPS, the main endpoint, the rate of change in the average number of brightness in the area where the tumor exists after 6 months, three groups are same, ie, 0.9. There was no difference. A difference in the average number of brightness in the area where the tumor exists after 6 months was examined. A tendency was observed that the number of brightness decreased.
Results date posted
| 2019 | Year | 07 | Month | 24 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
It was difficult to recruit for participntas.
Date of the first journal publication of results
Baseline Characteristics
There was no significant difference in age, height, weight, sex, medical history, and complications at the time of consent acquisition between the 0% propranol group, the 1% propranol group, and the 5% propranol group.
There was significant difference in gestational age and birth weight. In gestational age and birth weight, 1% propranol group had longer gestational age and heavier weight. In addition, 5% propranol, the gestational age was short in the group and the weight was light.
Participant flow
Of the 19 participants, one was unable to go to hospital and one was discontinued due to the onset of asthma. Two were excluded from PPS due to the use of concomitant drugs. Fifteen out of nineteen patients were adopted for PPS.
Adverse events
0 patients with hypotension, 0 patients with hypoglycemic attack, 1 patients with wheezing (1%), 0 with contact dermatitis, 4 with itching (0%; 1 person, 1%; 1 person, 5%; 2 person), 0 with pigmentation , 0 with depigmentation, 0 with skin atrophy.
10 patients with acute upper respiratory inflammation, 2 with influenza, 2 with acute gastroenteritis, 2 with otitis media, 3 with pruritus of the whole body, 3 with sebum deficiency and 2 with eczema
Outcome measures
Main endpoint
Change rate of the average number of brightness of the area where the tumor exists after 6 months
Secondary endpoints
Change in psychological anxiety, treatment satisfaction
Tumor area (long axis x short axis mm)
Patient compliance (frequency of external treatment actually performed)
Safety secondary evaluation items
Additional evaluation items
Difference in average number of brightness of the area where tumor exists after 6 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 16 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019892
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/07/24 | 実施計画書修正０１０９－２.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/07/24 | 20190605_解析図表ver1.3.xlsx |
