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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
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
Details
| Lead sponsor | Vietlife Healthcare Corporation |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 92 |
| Start date | 2019-07-05 |
| Completion | 2020-12-01 |
Conditions
- Cancer
Interventions
- CH1701 for prevention and treatment of radiation burns.
- Safety assessment of CH1701
- Placebos
Primary outcomes
- Side effects by skin biopsy — 14 days
Skin biopsy after 14 days of topical application, compared with healthy skin - Degree of burns according to CTCAE 4.03 atlas — 63 days
Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns
Countries
Vietnam