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

Phase 4

Completed

• Conditions: Scar
• Interventions: Drug: Fespixon cream; Drug: Placebo Cream

• Registration Number: NCT05271708
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

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 Timeline

• Study Start: 2022-01-05
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-27
• Study First Posted: 2022-03-09
• Primary Completion: 2022-10-17
• Study Completion: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fespixon cream	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.
Placebo Cream	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.

Primary Outcome Measures

Name	Time	Method
VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators	12-week	The VSS scores, assessed by 3 blind evaluators, changed from Day 1 to Week 12 will be used as an objective evidence.

Secondary Outcome Measures

Name	Time	Method
mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator	12-week	The mVSS scores, assessed by a Principal Investigator, changed from Day 1 to Week 12 will be used as an auxiliary evidence.
Hue feature-Red values via digital analysis at Day 1 and Week 12	12-week	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
Hue feature-Green values via digital analysis at Day 1 and Week 12	12-week	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
Hue feature-Blue values via digital analysis at Day 1 and Week 12	12-week	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
CIELab-lightness values via digital analysis at Day 1 and Week 12	12-week	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
CIELab-a values via digital analysis at Day 1 and Week 12	12-week	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
CIELab-b values via digital analysis at Day 1 and Week 12	12-week	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
Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12	12-week	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
Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12	12-week	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
Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12	12-week	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
VAS (Visual Analogue Scale) score at Week 12	12-week	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".
Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12	12-week	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

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei, Taiwan