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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Scar

Intervention / Treatment
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* Drug: Fespixon cream
* Drug: Placebo Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fespixon cream<br>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<br>* 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.<br>* Other names: ON101 cream;|
| Placebo Comparator: Placebo Cream<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fespixon, Thyroidectomy, caesarean section, Scar, ON101