Partial Thickness Burn Clinical Trial
Official title:
Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn
The objective of this Trial is to evaluate the performance of RPh201 as a treatment for the healing of partial thickness burns. It is further postulated that deep second degree lesions will benefit from the RPh201 treatment promoting granulation and epithelialization as well as wound closure.
The objective of this Trial is to evaluate the performance of RPh201 in the treatment of
partial thickness burns (second degree superficial and deep) of less than 5%TBSA.
The additional follow up for a period of 20 weeks will be scheduled to extend the evaluation
of wounds of Subjects that completed up to 3 weeks of treatment
This is to include:
- Efficacy assessment of burn improvement following the use of RPh2O1 oil solution
administered topically three times per week during an overall treatment period of up to
3 weeks and at the follow-up visit at 20 weeks after end of treatment in Subjects with
partial thickness burns (second degree superficial and deep) of less than 5%TBSA
- Safety evaluation of RPh201 formulated as an oil solution administered topically three
times per week during an overall treatment period of up to 3 weeks in Subjects with
partial thickness burns (second degree superficial and deep) of less than 5%TBSA.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02997592 -
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns
|
N/A |