Back to resultsOpen-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Primary Purpose
Pressure Injury Stage 2
Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Fespixon Cream
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Injury Stage 2 focused on measuring Fespixon, Pressure Injury, Wound, NPIAP Stage 2
Eligibility Criteria
1. Main inclusion criteria:
- At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae
- 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
2. Main exclusion criteria:
- 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 20 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.
Sites / Locations
- Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）Recruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- Taipei Medical University WanFang HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pressure Injury in Sacrum Wound
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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."
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."
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.
Full Information
NCT ID
NCT05317442
First Posted
March 30, 2022
Last Updated
March 16, 2023
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital, Oneness Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05317442
Brief Title
Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital, Oneness Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury Stage 2
Keywords
Fespixon, Pressure Injury, Wound, NPIAP Stage 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled
Open-label
Randomized: N/A
Single Arm
Duration of treatment: up to 16 weeks
Titration: no
Multi-center(Taiwan)
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pressure Injury in Sacrum Wound
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fespixon Cream
Other Intervention Name(s)
ON101 Cream
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of treatment-related Adverse Events associated with Fespixon cream
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Incidence of complete wound closure of the target ulcer area
Description
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."
Time Frame
16 weeks
Title
Time to complete wound closure of the target ulcer area
Description
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."
Time Frame
16 weeks
Title
Percentage of target ulcer wound area reduction at visit 9/ EOT (changed from V1 baseline)
Description
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
1. Main inclusion criteria:
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
2. Main exclusion criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Ju Lin
Phone
+886-2-930-7930
Ext
7772
Email
linda52091@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Chien Hung
Phone
+886-7-312-1101
Ext
7094
Email
orihaya2218@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsian-Jenn Wang
Organizational Affiliation
Taipei Medical University WanFang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shu-Hung Huang
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）
City
Kaohsiung City
ZIP/Postal Code
801
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-Chien Hung
Phone
+886-7-312-1101
Ext
7094
Email
orihaya2218@gmail.com
First Name & Middle Initial & Last Name & Degree
Shu-Hung Huang
First Name & Middle Initial & Last Name & Degree
Ya-Wei Lai
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun-Chien Hung
Phone
+886-7-312-1101
Ext
7094
Email
orihaya2218@gmail.com
First Name & Middle Initial & Last Name & Degree
Shu-Hung Huang
First Name & Middle Initial & Last Name & Degree
Ya-Wei Lai
Facility Name
Taipei Medical University WanFang Hospital
City
Taipei City
ZIP/Postal Code
10675
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Ju Lin
Phone
+886-2-930-7930
Ext
7772
Email
linda52091@gmail.com
First Name & Middle Initial & Last Name & Degree
Hsian-Jenn Wang
First Name & Middle Initial & Last Name & Degree
Wen-Kuan Chiu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IIT study
Learn more about this 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
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