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

NCT05317442 | Terminated Phase 4 FDA Drug

• 1 other identifier: ON101CLAS05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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

Conditions

Pressure Injury Stage 2

Keywords

Fespixon; Pressure Injury; Wound; NPIAP Stage 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of complete wound closure of the target ulcer area

  16 weeks

• Time to 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)

  16 weeks

Study Arms (1)

Pressure Injury in Sacrum and Greater Trochanter Wound

EXPERIMENTAL

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

Drug: Fespixon Cream

Interventions

Fespixon Cream DRUG

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

Also known as: ON101 Cream

Pressure Injury in Sacrum and Greater Trochanter Wound

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Oneness Biotech Co., Ltd.: collaborator

Study Sites (3)

Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）

Kaohsiung City, 801, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Taipei Medical University WanFang Hospital

Taipei, 10675, Taiwan

Location

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hsian-Jenn Wang

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

• Shu-Hung Huang

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Surgery

Model Details: 1. Uncontrolled 2. Open-label 3. Randomized: N/A 4. Single Arm 5. Duration of treatment: up to 16 weeks 6. Titration: no 7. Multi-center(Taiwan)

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: April 6, 2022
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)