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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017148
Receipt No. 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

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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
Email 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
Email rikihisa@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
URL(English) https://upload.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


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