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

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.

Study Overview

• Status: Completed
• Conditions: Scar
• Intervention / Treatment: Drug: Fespixon cream; Drug: Placebo Cream

Detailed Description

Methods: This study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. Bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. Treatment was given twice a day for 84 days. Assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the Vancouver Scar Scale/ modified Vancouver Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital, National Defense Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female aged over 20 years old (inclusive).
2. 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.

Exclusion Criteria:

1. Subjects who have previous neck or abdominal trauma that will affect the surgical incision site.
2. After radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason.

3. 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.

   1. Albumin < 2.5 g/dL (for subjects with severe malnutrition)
   2. HbA1c >12.0% (for subjects with severe diabetes)
   3. Liver function test [ aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
   4. Renal function test [Serum Creatinine] > 2x the upper limit of normal
4. Subject is currently receiving immunosuppressant or systemic corticosteroids.
5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fespixon cream; 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; 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.; Other Names: ON101 cream
Placebo Comparator: Placebo Cream; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator	The mVSS scores, assessed by a Principal Investigator, changed from Day 1 to Week 12 will be used as an auxiliary evidence.	12-week
VAS (Visual Analogue Scale) score at Week 12	VAS score (on a scale from 0 to 10) at Week 12 are used to present the satisfaction of participants. Zero means participants feel "not at all satisfied" and 10 means participants feel "completely satisfied".	12-week
Hue feature-Red values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
Hue feature-Green values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
Hue feature-Blue values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
CIELab-lightness values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
CIELab-a values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
CIELab-b values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week
Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative Δ ratio represents the difference of Δ ratio between Week 12 and Day1 out of baseline. NOTE1: Relative Δ ratio = (Week 12 Δ ratio - Day1 Δ ratio)/ Day1 Δ ratio NOTE2: Difference ratio= Δ ratio = Δ(scar-skin)/skin	12-week

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Investigators: Principal Investigator: Shao-Cheng Liu, PhD, Tri-Service General Hospital, National Defense Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 27, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: caesarean section; Scar; Thyroidectomy; Fespixon; ON101
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: B202105176; B202105176L (Other Identifier: Tri-Service General Hospital, National Defense Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No