NCT01455480

Trial To Evaluate RPh201 In Treatment Of Partial Thickness Burn

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Regenera Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Second Degree Burn Less Than 5%TBSA
• Partial Thickness Burn

Interventions

Type	Name	Description
DRUG	RPh201, botanical drug product	topical

Timeline

• Start date: 2011-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-10-20
• Last updated: 2016-12-06

Locations

1 site across 1 country: Israel