Venous Leg Ulcers (VLU)Phase 4NCT05322525

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

A Phase 4 study testing ON101 Cream in people with Venous Leg Ulcers (VLU), run by Oneness Biotech Co., Ltd. at 2 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Venous Leg Ulcers (VLU)
What is being tested?: ON101 Cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesTaiwan
Study dates: 23 Jun 2021to 15 Aug 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

About this study

Read the 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.

Conditions: Venous Leg Ulcers (VLU)
Being tested: ON101 Cream
Keywords: ON101, Fespixon, Venous leg ulcers, C6 or C6R

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ON101 CreamDrug
Also called Fespixon
Test drug:
1. Name: ON101
2. Dosage form: Topical cream
3. Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica
4. Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness)
5. Dosing schedule: Apply once a day

Study groups in NCT05322525
Study group	Role	What they receive
ON101 Cream	Experimental	Single arm of VLU group for ON101 Cream Test drug: 1. Name: ON101 2. Dosage form: Topical cream 3. Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica 4. Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply once a day Receives: Drug: ON101 Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Through study completion, an average of 6 months
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)
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
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)
Measured: Through study completion, an average of 6 months

Secondary outcomes (5)

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
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
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.
Measured: Through study completion, an average of 6 months
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
Measured: Through study completion, an average of 6 months
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
Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202115 Aug 2023

First posted12 Apr 2022
Study start23 Jun 2021
Primary completion15 Aug 2023
Study completion15 Aug 2023

Why it stopped: Due to the product development strategy adjustment, the Sponsor terminated this study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Venous Leg Ulcers (VLU)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05322525
Sponsor's protocol ID: ON101CLAS03
Status last verified: Mar 2025
First submitted: 22 Mar 2021
Last updated: 12 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: IIS study

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers

All Venous Leg Ulcers (VLU) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Research Study to Evaluate the Safety and Potential Efficacy of ON101 Cream for the Treatment of Venous Leg Ulcers.
ClinicalTrials.gov ID: NCT05322525
Acronym / sponsor ID: ON101CLAS03
Conditions: Venous Leg Ulcers (VLU)
Keywords: ON101, Fespixon, Venous leg ulcers, C6 or C6R
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the product development strategy adjustment, the Sponsor terminated this study.
Enrolment: 9 participants (actual)
Lead sponsor: Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Taipei Veterans General Hospital, Taiwan, Taipei Medical University Shuang Ho Hospital
Study start: 23 Jun 2021 (actual)
Primary completion: 15 Aug 2023 (actual)
Study completion: 15 Aug 2023 (actual)
First posted: 12 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.

Arm	Type	Receives
ON101 Cream	Experimental	Drug: ON101 CreamSingle arm of VLU group for ON101 Cream Test drug: 1. Name: ON101 2. Dosage form: Topical cream 3. Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica 4. Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply once a day

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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:

Key exclusion criteria (17 listed)

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:
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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ON101 CreamAlso: FespixonTest drug: 1. Name: ON101 2. Dosage form: Topical cream 3. Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica 4. Dose(s): Apply 1 cc per 5 cm2 ulcer size (not exceeding 2 mm in thickness) 5. Dosing schedule: Apply once a day	Drug	ON101 Cream

Primary outcome

Safety endpoint(1) : Treatment-Emergent Adverse Event
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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)

5 secondary outcomes

Efficacy endpoint(1): ulcer healing time measured
Time frame: Through study completion, an average of 6 months
Efficacy endpoint(2): complete healing of the target ulcer
Time frame: Through study completion, an average of 6 months
Efficacy endpoint(3): change from baseline in the target ulcer area
Time frame: Through study completion, an average of 6 months
Efficacy endpoint(4): percentage change from baseline in the target ulcer area
Time frame: Through study completion, an average of 6 months
Efficacy endpoint(5): between target ulcer area and time to complete ulcer healing
Time frame: Through study completion, an average of 6 months

Results and safety

The study was stopped early (reason given: Due to the product development strategy adjustment, the Sponsor terminated this study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Individual participant dataSharing planned: No. IIS study

Related trials for Venous Leg Ulcers (VLU)

Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shyi-Gen Chen, MD study director

Oneness Biotech Co., Ltd.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ON101 Cream in people with Venous Leg Ulcers (VLU), run by Oneness Biotech Co., Ltd. at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the product development strategy adjustment, the Sponsor terminated this study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety endpoint(1) : Treatment-Emergent Adverse Event (time frame: Through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05322525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.