A combined Phase I\&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
92
Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.
Safety assessment of CH1701 after 14 days of use on volunteers
The placebo was used on patients as a control for the doses of CH1701
Vietlife Healthcare Corporation
Hanoi, Vietnam
Side effects by skin biopsy
Skin biopsy after 14 days of topical application, compared with healthy skin
Time frame: 14 days
Degree of burns according to CTCAE 4.03 atlas
Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns
Time frame: 63 days
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