Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
- Registration Number
- NCT05317442
- Lead Sponsor
- Taipei Medical University WanFang Hospital
- Brief Summary
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
- Detailed Description
This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. During the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds.
At each visit, the size and changes of the target pressure ulcer are recorded by photographing. The target pressure ulcer area in the photo is calculated using Image Pro® PLUS software.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pressure Injury in Sacrum and Greater Trochanter Wound Fespixon Cream 1. Name: Fespixon Cream 2. Dosage form: Topical cream, 15 g ointment per tube 3. Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) 4. Dose(s): Apply 1 cc per 5 cm\^2 ulcer size (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply once a day 6. Duration: up to 16 weeks
- Primary Outcome Measures
Name Time Method Incidence of treatment-related Adverse Events associated with Fespixon cream 16 weeks Note:
* Assessment of Safety: Safety will be assessed based on the incidence of adverse events, including overall AEs, Fespixon-related AEs, target pressure ulcer-related AEs, and SAEs.
* During the trial, in addition to self-reported AEs, physicians will check physical examination, vital signs, and laboratory reports to determine the presence of AEs.
- Secondary Outcome Measures
Name Time Method Incidence of complete wound closure of the target ulcer area 16 weeks * According to "Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment" issued by the US FDA in June 2006, complete wound closure of target ulcer area is defined as "skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart"
* Time to complete wound closure of the target ulcer area was defined as "time to first visit of complete wound closure of the target ulcer area."Time to complete wound closure of the target ulcer area 16 weeks * According to "Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment" issued by the US FDA in June 2006, complete wound closure of target ulcer area is defined as "skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart"
* Time to complete wound closure of the target ulcer area was defined as "time to first visit of complete wound closure of the target ulcer area."Percentage of target ulcer wound area reduction at visit 9/ EOT (changed from V1 baseline) 16 weeks Take a photo of the target ulcer and use Image-Pro® Plus software to calculate the size of the target ulcer after taking photographs.The target ulcer wound area at the Visit 9/EOT will be compared to the area of the target ulcer at the baseline visit (Visit 1) and expressed in percentage.
Trial Locations
- Locations (3)
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Taipei Medical University WanFang Hospital
🇨🇳Taipei City, Taiwan
Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）
🇨🇳Kaohsiung City, Taiwan