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

JRCT ID: jRCTs031180234

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Infantile hemangioma
• Date of first enrollment: 09/10/2015
• Target sample size: 19
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

Primary Outcome

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.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Mitsukawa Nobuyuki
• Source(s) of Monetary Support: Chiba rosai hospital
• Secondary ID(s): UMIN000012123