Clinical trial
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Name
ON101CLAS05
Description
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Trial arms
Trial start
2022-04-06
Estimated PCD
2024-04-19
Trial end
2024-04-19
Status
Terminated
Phase
Early phase I
Treatment
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
Arms:
Pressure Injury in Sacrum and Greater Trochanter Wound
Other names:
ON101 Cream
Size
10
Primary endpoint
Incidence of treatment-related Adverse Events associated with Fespixon cream
16 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '1. Uncontrolled\n2. Open-label\n3. Randomized: N/A\n4. Single Arm\n5. Duration of treatment: up to 16 weeks\n6. Titration: no\n7. Multi-center(Taiwan)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2024-05-01
1 organization
1 product
1 indication
Organization
Taipei Medical University Wanfang HospitalProduct
FespixonIndication
Pressure Injury