TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
Condition: Donor Site Complication
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary objective:

        1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)
           for Phase I in terms of Incidence of treatment-related AEs and SAEs (including
           infections and bleeding)

        2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor
           site wounds (DSW) in terms of The healing time from DSW creation to 100%
           re-epithelialization

      Secondary objective:

        1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds
           (DSW) in secondary efficacy endpoints

        2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW)
           in secondary safety endpoints
    

Detailed description: 
      The study was designed to evaluate the safety and efficacy of the TWB-103 in adult subjects
      with split-thickness skin graft donor site wounds (DSW). In Phase I proportion, eligible
      subjects were recruited sequentially with one week staggering of treatment. Eligible subjects
      were randomized into TWB-103 or Placebo groups in a 1:1 ratio. Phase I was planned to recruit
      3 evaluable subjects each in TWB-103 and Placebo groups. Evaluable subjects in Phase I were
      (1) he/she who received at least one dose and had follow-up evaluation at least 14 days after
      the first dose or (2) he/she who received at least one dose and had early withdrawn due to
      safety reasons before Day 28. When all of those 6 evaluable subjects completed the planned
      treatment period (14 days or till first 100% re-epithelialization, which came first), the
      recruitment was temporarily stopped for 14 days for safety observation. The safety data
      before and on Day 28 Visit were reviewed by the sponsor and the principal investigator. If no
      safety issue was decided, the study would enter Phase II portion and eligible subjects would
      be randomized into a 1:1 ratio into one of the TWB-103 and Placebo groups. The dosing regimen
      designed in Phase II portion was the same as it was designed in Phase I portion.

      Subjects were instructed to attend scheduled visits at Screening, Day 0 (treatment start the
      day), Day 3, Day 7, Day 10, and Day 14 (end of treatment). All subjects were scheduled to
      attend a follow-up visit on Day 28 to evaluate the status of the target wound and then enter
      a 360-day follow-up phase. During the 360-day follow-up, four follow-up visits were scheduled
      at 90±14 days, 180±14 days, 270±14 days, and 360±14 days following the subject's Day 28 visit
      (if no Day 42 visit) or Day 42 visit.
    

Intervention name(s): TWB-103 Group; Placebo Group
Intervention type(s): Drug; Drug
Intervention description(s): Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.; Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
Other intervention name(s): TWB-103+Tegaderm; Placebo+Tegaderm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Donor Site Wounds