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

NCT05317442 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-01

No results posted yet for this study

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

Conditions

  • Pressure Injury Stage 2

Interventions

DRUG

Fespixon 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

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • Oneness Biotech Co., Ltd.

    collaborator INDUSTRY

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Hsian-Jenn Wang · Taipei Medical University WanFang Hospital

  • Shu-Hung Huang · Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2024-04-19
Completion
2024-04-19
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317442 on ClinicalTrials.gov