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A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.

Primary Purpose

Venous Leg Ulcers (VLU)

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
ON101 Cream
Sponsored by
Oneness Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Venous Leg Ulcers (VLU) focused on measuring ON101, Fespixon, Venous leg ulcers, C6 or C6R

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has signed a written informed consent prior to the study procedure
  2. Male or female aged at least 20 years old
  3. Venous outflow/venous capacitance (VO/VC) compatible with venous insufficiency measured at screening visit or within 3 months prior to enrollment
  4. Has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3 measured at screening visit or within 3 months prior to enrollment
  5. The target ulcer have all of the following characteristics:

    1. C6 or C6R per the Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) Classification System;
    2. Located between the knee and ankle (at or above the malleolus);
    3. No active infection;
    4. Post debridement ulcer area is ≥ 3 cm2 and ≤ 20 cm2 at the time of enrollment;
    5. Has been presented for at least 6 weeks before enrollment;
    6. A minimum of 2 cm margin between the qualified target ulcer and any other ulcers on the target limb (post debridement);
    7. Involves a full thickness skin loss, but without exposure of tendon, muscle, or bone;
    8. Must be nonhealing as defined as ≤ 30% reduction in ulcer area in response to standard of care (SoC) during the 2-week run-in period
  6. Considered by the Investigator to be compliant/adhere to the compression device during the 2-week run-in period
  7. If female of child-bearing potential, has a negative pregnancy test on urine at screening and must not be breastfeeding
  8. Able and willing to attend the scheduled visits and comply with the study procedures.

Exclusion Criteria:

  1. Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
  2. With deep vein thrombosis within 4 weeks prior to enrollment
  3. Has endovenous surgery planned or performed within 4 weeks prior to enrollment
  4. Laboratory values at Screening of:

    1. Liver function test (total bilirubin, aspartate aminotransferase [AST], or alanine aminotransferase [ALT]) > 3x the upper limit of normal, or
    2. Poor nutritional status defined as albumin < 2.5 g/dL, or
    3. Renal function test (serum creatinine) > 2x the upper limit of normal, or
    4. Glycosylated hemoglobin (HbA1c) ≥ 9 %
  5. Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the Investigator, could interfere with ulcer healing, including but not limited to the following:

    1. Systemic infection not controlled by suitable antibiotic treatment
    2. Active malignant disease. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, maybe considered for study entry.
    3. Acquired immune deficiency syndrome (AIDS) or HIV positive
  6. Has received treatment with immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 4 weeks prior to enrollment
  7. Heavy smoker (≥ 20 cigarettes per day)
  8. Use of any investigational drug or therapy within 4 weeks prior to enrollment
  9. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which in the opinion of the Investigator, may pose a threat to subject compliance
  10. Judged by the Investigator to be not suitable for study participation

Sites / Locations

  • Taipei Medical University Shuang Ho HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ON101 Cream

Arm Description

Single arm of VLU group for ON101 Cream Test drug: Name: ON101 Dosage form: Topical cream Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day

Outcomes

Primary Outcome Measures

Safety endpoint(1) : Treatment-Emergent Adverse Event
Incidence of treatment-emergent adverse event (TEAE); safety will be assessed by the incidence of adverse events, including overall AEs, AEs related to the ON101, study-ulcer-associated AEs and SAEs.
Safety endpoint(2-1) : Change from baseline in vital signs
Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs:pulse rate(times/min), SBP/DBP(mmHg), Body Temperature (°C), and respiratory rate ( breaths/min)
Safety endpoint(2-2) : Change from baseline in physical examination
Incidence of treatment-emergent adverse event (AE) Change from baseline in the physical examination: HEENT (head, eyes, ears, nose, and throat), mouth, skin, neck (including thyroid), lymph nodes, spine, cardiovascular system, respiratory system, gastrointestinal system, nervous system, musculoskeletal system, blood and blood-forming organs and mental status.
Safety endpoint(2-3) : Change from baseline in laboratory test
Incidence of treatment-emergent adverse event (AE) Change from baseline in laboratory tests: Complete blood count (WBC, Neutrophils, Monocytes, Hb, MCV, MCH, MCHC, Platelet), Biochemistry (HbA1c, fasting blood glucose, triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine, albumin), and Urinalysis (pH, protein, glucose, ketone, blood, urobilinogen, bilirubin, nitrite, leukocyte)
Safety endpoint(3) : Target ulcer infection
Incidence of target ulcer infection
Safety Analysis through the descriptive statistics
Treatment-emergent adverse events will be analyzed mainly with descriptive statistics. The frequency, percentage of subjects, severity, and the relationship with study drug of adverse events will be listed. The continuous variables (e.g., vital signs and laboratory value) will be described using the number of observation, mean, standard deviation, median, range (min, max), and 95% confidence interval. Other categorical variables (e.g., physical examination) will be described using frequencies and proportion or the frequency of normality/abnormality. TEAEs will be coded using MedDRA (version 23.1 or later) and grouped by system organ class and preferred term and events.

Secondary Outcome Measures

Efficacy endpoint(1): ulcer healing time measured
Time to complete ulcer healing:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed
Efficacy endpoint(2): complete healing of the target ulcer
Incidence of complete healing of the target ulcer:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Efficacy endpoint(3): change from baseline in the target ulcer area
Mean change from baseline in the target ulcer area:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Efficacy endpoint(4): percentage change from baseline in the target ulcer area
Percentage change from baseline in the target ulcer area:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed
Efficacy endpoint(5): between target ulcer area and time to complete ulcer healing
Correlation between target ulcer area and time to complete ulcer healing:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed

Full Information

First Posted
March 22, 2021
Last Updated
March 28, 2023
Sponsor
Oneness Biotech Co., Ltd.
Collaborators
Taipei Veterans General Hospital, Taiwan, Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05322525
Brief Title
A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.
Official Title
A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oneness Biotech Co., Ltd.
Collaborators
Taipei Veterans General Hospital, Taiwan, Taipei Medical University Shuang Ho Hospital

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
A Research Study to evaluate the safety and potential efficacy of ON101 cream for the treatment of venous leg ulcers.The objectives of the study are to determine the safety and to explore the potential efficacy of ON101 cream in patients with venous leg ulcers.
Detailed Description
This is a multi-center, open-label study to investigate the Safety and Potential Efficacy of ON101 Cream in Venous Leg Ulcers (VLU) patients. Subjects with VLU of CEAP C6 (active venous ulcer) or C6R (recurrent active venous ulcer) are to be included in this study. If a subject has more than one ulcer on the leg, the most severe ulcer then the largest ulcer that confirm to meet the eligibility criteria will be selected for study evaluation. 12 eligible subjects will be enrolled and receive ON101 cream treatment. Enrolled subjects will be instructed to apply the study treatment on the selected target ulcer for a maximum of 18 weeks, until the ulcer complete closure (ulcer size of 0) for two consecutive visits that at least 2 weeks apart, or until the subject exit the study prematurely due to any reason. Identical standard of care (SoC) procedure will be performed in both the control and investigational product arms throughout the study period, which including ulcer cleansing, debridement if necessary, and application of a suitable dressing and compression system until complete ulcer closure. Subjects are required to apply compression device at least 8 hours per day throughout the treatment period. The study consists of three periods, a 2-week Screening/Run-in period, an up-to-18-week Treatment period, and a 1-to-2-week Follow-up period. The Screening/Run-in period is to ensure the subjects' eligibility and their compliance to compression therapy and to exclude subjects who demonstrate substantial healing resulting solely from improved compliance with SoC. The Treatment period is to determine the safety and to explore the potential efficacy of the study product. The Follow-up period is to assess the safety. During the Follow-up period, SoC will be provided to subjects with non-healing or recurrent target ulcer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers (VLU)
Keywords
ON101, Fespixon, Venous leg ulcers, C6 or C6R

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ON101 Cream
Arm Type
Experimental
Arm Description
Single arm of VLU group for ON101 Cream Test drug: Name: ON101 Dosage form: Topical cream Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day
Intervention Type
Drug
Intervention Name(s)
ON101 Cream
Other Intervention Name(s)
Fespixon
Intervention Description
Test drug: Name: ON101 Dosage form: Topical cream Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) Dosing schedule: Apply once a day
Primary Outcome Measure Information:
Title
Safety endpoint(1) : Treatment-Emergent Adverse Event
Description
Incidence of treatment-emergent adverse event (TEAE); safety will be assessed by the incidence of adverse events, including overall AEs, AEs related to the ON101, study-ulcer-associated AEs and SAEs.
Time Frame
Through study completion, an average of 6 months
Title
Safety endpoint(2-1) : Change from baseline in vital signs
Description
Incidence of treatment-emergent adverse event (AE) Change from baseline in vital signs:pulse rate(times/min), SBP/DBP(mmHg), Body Temperature (°C), and respiratory rate ( breaths/min)
Time Frame
Through study completion, an average of 6 months
Title
Safety endpoint(2-2) : Change from baseline in physical examination
Description
Incidence of treatment-emergent adverse event (AE) Change from baseline in the physical examination: HEENT (head, eyes, ears, nose, and throat), mouth, skin, neck (including thyroid), lymph nodes, spine, cardiovascular system, respiratory system, gastrointestinal system, nervous system, musculoskeletal system, blood and blood-forming organs and mental status.
Time Frame
Through study completion, an average of 6 months
Title
Safety endpoint(2-3) : Change from baseline in laboratory test
Description
Incidence of treatment-emergent adverse event (AE) Change from baseline in laboratory tests: Complete blood count (WBC, Neutrophils, Monocytes, Hb, MCV, MCH, MCHC, Platelet), Biochemistry (HbA1c, fasting blood glucose, triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine, albumin), and Urinalysis (pH, protein, glucose, ketone, blood, urobilinogen, bilirubin, nitrite, leukocyte)
Time Frame
Through study completion, an average of 6 months
Title
Safety endpoint(3) : Target ulcer infection
Description
Incidence of target ulcer infection
Time Frame
Through study completion, an average of 6 months
Title
Safety Analysis through the descriptive statistics
Description
Treatment-emergent adverse events will be analyzed mainly with descriptive statistics. The frequency, percentage of subjects, severity, and the relationship with study drug of adverse events will be listed. The continuous variables (e.g., vital signs and laboratory value) will be described using the number of observation, mean, standard deviation, median, range (min, max), and 95% confidence interval. Other categorical variables (e.g., physical examination) will be described using frequencies and proportion or the frequency of normality/abnormality. TEAEs will be coded using MedDRA (version 23.1 or later) and grouped by system organ class and preferred term and events.
Time Frame
Through study completion, an average of 1 year for the final review.
Secondary Outcome Measure Information:
Title
Efficacy endpoint(1): ulcer healing time measured
Description
Time to complete ulcer healing:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed
Time Frame
Through study completion, an average of 6 months
Title
Efficacy endpoint(2): complete healing of the target ulcer
Description
Incidence of complete healing of the target ulcer:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Time Frame
Through study completion, an average of 6 months
Title
Efficacy endpoint(3): change from baseline in the target ulcer area
Description
Mean change from baseline in the target ulcer area:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed.
Time Frame
Through study completion, an average of 6 months
Title
Efficacy endpoint(4): percentage change from baseline in the target ulcer area
Description
Percentage change from baseline in the target ulcer area:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed
Time Frame
Through study completion, an average of 6 months
Title
Efficacy endpoint(5): between target ulcer area and time to complete ulcer healing
Description
Correlation between target ulcer area and time to complete ulcer healing:measured by the photo to ensure the target ulcer area, such as length, width,and depth changed
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has signed a written informed consent prior to the study procedure Male or female aged at least 20 years old Venous outflow/venous capacitance (VO/VC) compatible with venous insufficiency measured at screening visit or within 3 months prior to enrollment Has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3 measured at screening visit or within 3 months prior to enrollment The target ulcer have all of the following characteristics: C6 or C6R per the Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) Classification System; Located between the knee and ankle (at or above the malleolus); No active infection; Post debridement ulcer area is ≥ 3 cm2 and ≤ 20 cm2 at the time of enrollment; Has been presented for at least 6 weeks before enrollment; A minimum of 2 cm margin between the qualified target ulcer and any other ulcers on the target limb (post debridement); Involves a full thickness skin loss, but without exposure of tendon, muscle, or bone; Must be nonhealing as defined as ≤ 30% reduction in ulcer area in response to standard of care (SoC) during the 2-week run-in period Considered by the Investigator to be compliant/adhere to the compression device during the 2-week run-in period If female of child-bearing potential, has a negative pregnancy test on urine at screening and must not be breastfeeding Able and willing to attend the scheduled visits and comply with the study procedures. Exclusion Criteria: Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement With deep vein thrombosis within 4 weeks prior to enrollment Has endovenous surgery planned or performed within 4 weeks prior to enrollment Laboratory values at Screening of: Liver function test (total bilirubin, aspartate aminotransferase [AST], or alanine aminotransferase [ALT]) > 3x the upper limit of normal, or Poor nutritional status defined as albumin < 2.5 g/dL, or Renal function test (serum creatinine) > 2x the upper limit of normal, or Glycosylated hemoglobin (HbA1c) ≥ 9 % Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the Investigator, could interfere with ulcer healing, including but not limited to the following: Systemic infection not controlled by suitable antibiotic treatment Active malignant disease. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, maybe considered for study entry. Acquired immune deficiency syndrome (AIDS) or HIV positive Has received treatment with immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 4 weeks prior to enrollment Heavy smoker (≥ 20 cigarettes per day) Use of any investigational drug or therapy within 4 weeks prior to enrollment A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which in the opinion of the Investigator, may pose a threat to subject compliance Judged by the Investigator to be not suitable for study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jui-ching Chen, PhD
Phone
886-2-2703-1098
Ext
358
Email
juiching.chen@microbio.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-ting Kuo, MS
Phone
886-2-2703-1098
Ext
562
Email
cathy.kuo@onenessbio.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyi-Gen Chen, MD
Organizational Affiliation
Oneness Biotech Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun-Cheng Chang, MD
Phone
886-2-22490088
Email
csc901515@gmail.com
First Name & Middle Initial & Last Name & Degree
Shun-Cheng Chang, MD
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szu-Hsien Wu, MD
Phone
886-2-28712121
Email
shwu3@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Szu-Hsien Wu, MD
First Name & Middle Initial & Last Name & Degree
Yu-Chung Shih, MD
First Name & Middle Initial & Last Name & Degree
Ching-En Chen, MD
First Name & Middle Initial & Last Name & Degree
Yu-Jen Chiu, MD
First Name & Middle Initial & Last Name & Degree
Fu-Yin Hsiao, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IIS study

Learn more about this trial

A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.

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