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

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

• Status: Terminated
• Conditions: Pressure Injury Stage 2
• Intervention / Treatment: Drug: Fespixon Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 801
    • Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）
  • Taipei City, Taiwan, 10675
    • Taipei Medical University WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

1. Main inclusion criteria:

1. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter
2. NPUAP is classified as stage 2
3. No active infection, i.e., IDSA level 1
4. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)
5. 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:

1. 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
2. Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30 mg/dL)
3. Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal; serum creatinine > 3× the upper limit of normal)
4. Pregnant or lactating women
5. Infected with human immunodeficiency virus
6. Body mass index (BMI) less than 18.5 kg/m²
7. Unable to cooperate with changing of subject's position
8. Patients with anemia (Hgb < 7.0 g/dL).
9. Unable to prevent contaminations such as feces or urinary incontinence
10. Malnutrition (Albumin< 2.5 g/dL)
11. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer
12. In the opinion of the investigator, entering this trial may pose a threat to subject compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pressure Injury in Sacrum and Greater Trochanter Wound; 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; 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; 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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Collaborators: Kaohsiung Medical University Chung-Ho Memorial Hospital; Oneness Biotech Co., Ltd.
• Investigators: Principal Investigator: Hsian-Jenn Wang, Taipei Medical University WanFang Hospital; Principal Investigator: Shu-Hung Huang, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Wound; Fespixon; Pressure Injury; NPIAP Stage 2
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: ON101CLAS05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IIT study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No