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

NCT ID: NCT05317442

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2024-04-19

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.

Conditions

Pressure Injury Stage 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pressure Injury in Sacrum and Greater Trochanter Wound

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

Group Type: EXPERIMENTAL

Fespixon Cream

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

ON101 Cream

Eligibility Criteria

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: collaborator

Oneness Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsian-Jenn Wang

Consultant, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsian-Jenn Wang

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University WanFang Hospital

Shu-Hung Huang

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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

Kaohsiung City, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Taipei Medical University WanFang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

ON101CLAS05

Identifier Type: -

Identifier Source: org_study_id