Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery

NCT05271708 | Completed Phase 4 FDA Drug

• 2 other identifiers: B202105176B202105176L
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of the Fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.

Conditions

Scar

Keywords

Fespixon; Thyroidectomy; caesarean section; Scar; ON101

Outcome Measures

Primary Outcomes (1)

• VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators

  The VSS scores, assessed by 3 blind evaluators, changed from Day 1 to Week 12 will be used as an objective evidence.

  12-week

Secondary Outcomes (12)

• mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator

  12-week

• Hue feature-Red values via digital analysis at Day 1 and Week 12

  12-week

• Hue feature-Green values via digital analysis at Day 1 and Week 12

  12-week

• Hue feature-Blue values via digital analysis at Day 1 and Week 12

  12-week

• CIELab-lightness values via digital analysis at Day 1 and Week 12

  12-week

Study Arms (2)

Fespixon cream

EXPERIMENTAL

Fespixon cream contains 1.25% extracts of Plectranthus amboinicus (PA-F4, 0.25%) and Centella asiatica (S1, 1%) with appearance in yellow-green to light green color. Fespixon cream will be applied twice daily for up to 12 weeks to the linear wound.

Drug: Fespixon cream

Placebo Cream

PLACEBO COMPARATOR

Placebo cream with appearance in yellow-green to light green color, same appearance as Fespixon cream, will be applied twice daily for up to 12 weeks to the linear wound.

Drug: Placebo Cream

Interventions

Fespixon cream DRUG

Bounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days.

Also known as: ON101 cream

Fespixon cream

Placebo Cream DRUG

Bounded by the midpoint of the scar, each patient received two topical scar formulations consisting of Fespixon cream on one side, and placebo cream on the other side. Treatment was given twice a day for 84 days.

Placebo Cream

Eligibility Criteria

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

You may qualify if:

• Male or female aged over 20 years old (inclusive).
• Subjects with linear scar in neck or abdomen following elective surgery, including thyroid and parathyroid surgery, excision of neck mass, caesarean section, trans-abdominal hysterectomy, trans-abdominal myomectomy or any neck or abdominal surgeries which can be managed by primary closure of clean surgical wounds.

You may not qualify if:

• Subjects who have previous neck or abdominal trauma that will affect the surgical incision site.
• After radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason.
• Laboratory values at Screening of:
• Note: The investigator will decide which of the following laboratory tests should be performed considering the condition of the subject.
• Albumin \< 2.5 g/dL (for subjects with severe malnutrition)
• HbA1c \>12.0% (for subjects with severe diabetes)
• Liver function test \[ aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Renal function test \[Serum Creatinine\] \> 2x the upper limit of normal
• Subject is currently receiving immunosuppressant or systemic corticosteroids.
• Has any other factor which may, in the opinion of the investigator, compromise participation in the study.(Including subjects with medical history of keloid or hypertrophic scar).

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shao-Cheng Liu, PhD

  Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes (VSS score) assessors do not know which side is applied with the therapeutic ointment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The patient's wound was treated with a placebo or therapeutic ointment on the right side and a placebo or therapeutic ointmenton the left side.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 9, 2022
• Study Start: January 5, 2022
• Primary Completion: October 17, 2022
• Study Completion: November 30, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)