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

Taipei Medical University

Status and phase: Terminated; Phase 4

Conditions: Pressure Injury Stage 2

Treatments: Drug: Fespixon Cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05317442

ON101CLAS05

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Main inclusion criteria:

2. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter

3. NPUAP is classified as stage 2

4. No active infection, i.e., IDSA level 1

5. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)

6. 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

7. Main exclusion criteria:

8. 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

9. Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30 mg/dL)

10. Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal; serum creatinine > 3× the upper limit of normal)

11. Pregnant or lactating women

12. Infected with human immunodeficiency virus

13. Body mass index (BMI) less than 18.5 kg/m²

14. Unable to cooperate with changing of subject's position

15. Patients with anemia (Hgb < 7.0 g/dL).

16. Unable to prevent contaminations such as feces or urinary incontinence

17. Malnutrition (Albumin< 2.5 g/dL)

18. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer

19. In the opinion of the investigator, entering this trial may pose a threat to subject compliance.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pressure Injury in Sacrum and Greater Trochanter Wound

Experimental group

Description:

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

Treatment:

Drug: Fespixon Cream