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

NCT05322525 | Terminated Phase 4 FDA Drug

• 1 other identifier: ON101CLAS03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Leg Ulcers (VLU)

Keywords

ON101; Fespixon; Venous leg ulcers; C6 or C6R

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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.

  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)

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• Efficacy endpoint(1): ulcer healing time measured

  Through study completion, an average of 6 months

• Efficacy endpoint(2): complete healing of the target ulcer

  Through study completion, an average of 6 months

• Efficacy endpoint(3): change from baseline in the target ulcer area

  Through study completion, an average of 6 months

• Efficacy endpoint(4): percentage change from baseline in the target ulcer area

  Through study completion, an average of 6 months

• Efficacy endpoint(5): between target ulcer area and time to complete ulcer healing

  Through study completion, an average of 6 months

Study Arms (1)

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

Drug: ON101 Cream

Interventions

ON101 Cream DRUG

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

Also known as: Fespixon

ON101 Cream

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator

Study Sites (2)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Study Officials

• Shyi-Gen Chen, MD

  Oneness Biotech Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of 3 periods, a Screening/Run-in period, a treatment period, and a follow-up period.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 12, 2022
• Study Start: June 23, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)