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Comparative test on the effectiveness and safety of B blocker topical treatment with different concentrations of active ingredients against superficial infantile hemangioma (Comparative test on the effectiveness and safety of B blocker topical treatment with different concentrations of active ingredients against superficial infantile hemangioma)

Comparative test of B blocker topical treatment with different concentrations of active ingredients against infantile hemangioma (Comparative test of B blocker topical treatment with different concentrations of active ingredients against infantile hemangioma)

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Superficial and mixed type infantile hemangioma. More than 50% of tumor is present on the skin surface in lesion 0% group; total 7 cases (1 male and 6 females), age range 2 1% group; total 6 cases (1 male and 5 females), age range 2-5 5% group; total 6 cases (no male and 6 females), age range 2-8

Data fixation, Per protocol set 0% group; total 7 cases (1 male and 6 females), age range 2 1% group; total 4 cases (1 male and 3 females), age range 2-5 5% group; total 4 cases (no male and 4 females), age range 2-8

There were 4 cases of pruritus in the application area. There was one case of onset asthma, but the causal relationship with B-blocker application was unknown. In addition, influenza and infectious gastroenteric were observed.

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, i.e., 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.

The topical propranolol gel did not diminish the redness of IH after the proliferative phase in Japanese pediatric patients. However, our results imply that the topical propranolol gel has a limited effect on the satisfaction of parents and a favorable safety profile.

Dec. 31, 2020

Jan. 01, 2022

https://www.jstage.jst.go.jp/article/bpb/45/1/45_b2100500/_article

No

No plan

https://jrct.niph.go.jp/latest-detail/jRCTs031180234

Mitsukawa Nobuyuki

Chiba University Hospital

Inohana1-8-1 Chuo-ku Chiba Chiba, Japan

nmitsu@faculty.chiba-u.jp

Rikihisa Naoaki

Chiba University Hospital

Inohana1-8-1 Chuo-ku Chiba Chiba, Japan

+81-43-222-7171

rikihisa@faculty.chiba-u.jp

Complete

Oct. 01, 2015

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

Superficial and mixed type infantile hemangioma.
More than 50% of tumor is present on the skin surface in lesion

1. Patients with asthma. Cases with Asthma suspected
2. Cardiovascular malformation patients. Cases with cardiovascular malformations suspected
3. Patients with impaired cardiac function. Cases with heart function decline suspected
4. Diabetic patients. Diabetes suspected cases
5. Patients with severe liver and kidney function disorder
6. Patients with thyrotoxicosis, Pheochromocytoma patients
7. Patients with non-severe and severe peripheral circulatory failure
8. Case of poor weight gain
9. A case using the following drugs. adrenaline, catecholamine depleting agent, B-blocking agent, calcium antagonist, digitalis preparation, drug having CYP 2D 6 inhibitory action, (quinidine sulfate hydrate selective serotonin reuptake inhibitor), immunosuppressant.
10. Drying, papules, pustules, erosions, desquamation, lichen, crusts in affected areas

Both

Infantile hemangioma

Apply 0% or 1% or 5% propranolol ointment twice daily for 6 months. Apply an ointment with one little finger head size per 200 cm2 over the entire tumor over 5 seconds.

Infantile hemangioma, Strawberry mark

021

Change rate of tumor color tone
The rate of change is defined as follows.
Tumor average pixel value before treatment / average tumor pixel value after treatment
The tumor is red to bluish purple color. When decomposing a picture of tumor into RGB images, the tumor has less green light than healthy skin. Using this fact, we evaluate the change of the tumor color approaching the healthy skin.
We adjust the color tone of tumor picture with Photoshop. Furthermore, the picture (8 bit, TIFF) is converted to RGB image (red, blue, green) using Image J (image analysis software) and it is replaced with 256 gray scale grayscale image. When reversing black and white, the healthy skin is black and the tumor is drawn white. An average value (0 to 255) of the image luminance of the tumor area is calculated using Image J.

Tumor area (long axis by short axis).
Actual frequency of external use (compliance).
Questionnaire survey conducted before and after treatment to evaluate changes in psychological burden on lesions and satisfaction for this treatment

+81-43-226-2616

Feb. 27, 2019

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