Health Condition 1: L589- Radiodermatitis, unspecified
Conditions
Interventions
Intervention1: VL-RD-01: 0.28g/ adjudication (1 adjudication/16cm2 of area), Topical gel, Twice a day, for approximately 9 weeks
Control Intervention1: Placebo: (1 adjudication/ 16 cm2 area), Topical
Sponsors
Gangwal Healthcare Pvt Ltd
Verisearch Lab Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged greater than and equal to 18 years old and less than and equal to 60 years old. 2. Physically active as indicated by Karnofsky Performance Status scale greater than 60 requiring no assistance in day to day activity. 3. Patient with histologically confirmed epithelial carcinoma of the head and neck namely oral cavity, oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands undergoing radiotherapy. 4. Patients with TNM staging of T1-4 N0-2 M0. 5. Patient with grade 0 skin assessment as assessed using the Radiation Therapy Oncology Group RTOG. 6. Patients with a negative patch test result to the study products. 7. Patients planned to receive postoperative or curative RT total radiation dose of at least 60 Gy with or without concurrent chemotherapy. 8. Patients are literate enough to understand and comply with the study procedure. 9. Patients willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with previous radiation therapy to the treatment area. 2. Patient receiving brachytherapy. 3. Patients scheduled to receive hypofractionation less than 60 Gy radiotherapy. 4. Patients with active rash pre existing dermatitis or other conditions within the treatment area that may make skin assessment for the study difficult per the treating physicians discretion. 5. Patients seropositive for HIV. 6. Cutaneous and or connective tissue diseases i.e. lupus erythematosus or scleroderma. 7. Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure. 8. Use of over the counter topical medications containing steroids. 9. Presence of unhealed wounds in the radiation field. 10. Pregnant or lactating Female. 11. Participated in other clinical trials within the last 3 months Study Withdrawal Criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of Proprietary Gel in reducing the incidence of grade greater than or equal to 2 skin toxicity as per Radiation Oncology Toxicity grading RTOG, as assessed by proportion of subjects having greater than Grade 2 acute skin toxicity at the end of Radiotherapy RT, as compared to placebo arms.Timepoint: Baseline, Radiation Therapy Visits, End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Reducing the incidence of grade greater than and equal to 2 radiation dermatitis as per Common Terminology Criteria for Adverse Events CTCAE 5.0, as assessed by proportion of subjects without G2 RD at the end of Radiotherapy RT, as compared to placebo arms.Timepoint: Baseline, Radiation Therapy Visits, End of Study;Worst skin toxicity during treatment and up to 2 weeks after the last radiation, as assessed by the maximum grade of radiation dermatitis as per Common Terminology Criteria for Adverse Events CTCAE v.5.0.Timepoint: Baseline, Radiation Therapy Visits, End of Study;Radiation Induced Skin Reaction Assessment Scale RISRAS assessed by patient and oncologist.Timepoint: Baseline, End of Radiation Therapy Visit, End of Study;Patient reported QOL using the Skindex 1Timepoint: Baseline, End of Radiation Therapy Visit, End of Study;Number of Participants with Progression of Radiotherapy Induced Skin ReactionTimepoint: Baseline, Radiation Therapy Visits, End of Study;Patient global satisfaction score.Timepoint: End of Radiation Therapy visit, End of Study | — |
Countries
India
Contacts
Public ContactMs Megha Barge
Bioaxion Innovation
Outcome results
None listed