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Pressure Injury Stage 2Phase 4NCT05317442

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

A Phase 4 study testing Fespixon Cream in people with Pressure Injury Stage 2, run by Taipei Medical University WanFang Hospital at 3 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

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

Who is it for?
Ages 20 to 99 years
Conditions the study is for
Pressure Injury Stage 2
What is being tested?
Fespixon Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesTaiwan
Study dates
6 Apr 2022to 19 Apr 2024
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Main inclusion criteria:
  2. At least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter
  3. NPUAP is classified as stage 2
  4. No active infection, i.e., IDSA level 1
  5. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment)
  6. 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
  7. Main exclusion criteria:
  8. 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
  9. Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30 mg/dL)
  10. Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal; serum creatinine > 3× the upper limit of normal)
  11. Pregnant or lactating women
  12. Infected with human immunodeficiency virus
  13. Body mass index (BMI) less than 18.5 kg/m²
  14. Unable to cooperate with changing of subject's position
  15. Patients with anemia (Hgb < 7.0 g/dL).
  16. Unable to prevent contaminations such as feces or urinary incontinence
  17. Malnutrition (Albumin< 2.5 g/dL)
  18. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer
  19. In the opinion of the investigator, entering this trial may pose a threat to subject compliance.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

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

    Kaohsiung City, 801

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Taipei Medical University WanFang Hospital

    Taipei, 10675

Other trials in Taiwan

About this study

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

Read the 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.

Being tested
Fespixon Cream
Keywords
Fespixon, Pressure Injury, Wound, NPIAP Stage 2
Medical subject headings
Pressure Ulcer, Wounds and Injuries

What participants receive

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

  • Fespixon CreamDrug

    Also called ON101 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
Study groups in NCT05317442
Study groupRoleWhat they receive
Pressure Injury in Sacrum and Greater Trochanter WoundExperimental1. 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
Receives: Drug: Fespixon Cream

What is being measured

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

  1. 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.

    Measured: 16 weeks

Secondary outcomes (3)

  1. 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."

    Measured: 16 weeks

  2. 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."

    Measured: 16 weeks

  3. 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.

    Measured: 16 weeks

Timeline

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

  1. First posted7 Apr 2022
  2. Study start6 Apr 2022
  3. Primary completion19 Apr 2024
  4. Study completion19 Apr 2024

Why it stopped: Study halted prematurely and will not resume.

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
1. Uncontrolled 2. Open-label 3. Randomized: N/A 4. Single Arm 5. Duration of treatment: up to 16 weeks 6. Titration: no 7. Multi-center(Taiwan)
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05317442
Sponsor's protocol ID
ON101CLAS05
Status last verified
Apr 2024
First submitted
30 Mar 2022
Last updated
1 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IIT study

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fespixon Cream in people with Pressure Injury Stage 2, run by Taipei Medical University WanFang Hospital at 3 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?

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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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: Study halted prematurely and will not resume.). 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?

Incidence of treatment-related Adverse Events associated with Fespixon cream (time frame: 16 weeks). 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 NCT05317442.

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 1 May 2024.

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