Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound

Study Overview
=================
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.

Official Title
-----------------
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound

Conditions
-----------------
Pressure Injury Stage 2

Intervention / Treatment
-----------------
* Drug: Fespixon Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
1. Main inclusion criteria: At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter NPUAP is classified as stage 2 No active infection, i.e., IDSA level 1 Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment) If an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination 2. Main exclusion criteria: Those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, Plectranthus amboinicus, Centella asiatica or excipients Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30 mg/dL) Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal; serum creatinine > 3× the upper limit of normal) Pregnant or lactating women Infected with human immunodeficiency virus Body mass index (BMI) less than 18.5 kg/m² Unable to cooperate with changing of subject's position Patients with anemia (Hgb < 7.0 g/dL). Unable to prevent contaminations such as feces or urinary incontinence Malnutrition (Albumin< 2.5 g/dL) Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer In the opinion of the investigator, entering this trial may pose a threat to subject compliance.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Uncontrolled Open-label Randomized: N/A Single Arm Duration of treatment: up to 16 weeks Titration: no Multi-center(Taiwan)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure Injury in Sacrum Wound<br>Name: Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day Duration: up to 16 weeks | Drug: Fespixon Cream<br>* Name: Fespixon Cream Dosage form: Topical cream, 15 g ointment per tube Active ingredients: 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) Dose(s): Apply 1 cc per 5 cm^2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day Duration: up to 16 weeks<br>* Other names: ON101 Cream;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related Adverse Events associated with Fespixon cream | 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete wound closure of the target ulcer area | 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. | 16 weeks | 
| Time to complete wound closure of the target ulcer area | 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. | 16 weeks | 
| Percentage of target ulcer wound area reduction at visit 9/ EOT (changed from V1 baseline) | 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. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fespixon, Pressure Injury, Wound, NPIAP Stage 2