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

Primary Purpose

Scar

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Fespixon cream
Placebo Cream
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring Fespixon, Thyroidectomy, caesarean section, Scar, ON101

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tri-Service General Hospital, National Defense Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fespixon cream

Placebo Cream

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
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
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
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
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
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
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
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
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
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".

Full Information

First Posted
February 15, 2022
Last Updated
December 23, 2022
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05271708
Brief Title
Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery
Official Title
Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Fespixon, Thyroidectomy, caesarean section, Scar, ON101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Participants and outcomes (VSS score) assessors do not know which side is applied with the therapeutic ointment.
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fespixon cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fespixon cream
Other Intervention Name(s)
ON101 cream
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators
Description
The VSS scores, assessed by 3 blind evaluators, changed from Day 1 to Week 12 will be used as an objective evidence.
Time Frame
12-week
Secondary Outcome Measure Information:
Title
mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator
Description
The mVSS scores, assessed by a Principal Investigator, changed from Day 1 to Week 12 will be used as an auxiliary evidence.
Time Frame
12-week
Title
Hue feature-Red values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
Hue feature-Green values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
Hue feature-Blue values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
CIELab-lightness values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
CIELab-a values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
CIELab-b values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12
Description
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
Time Frame
12-week
Title
VAS (Visual Analogue Scale) score at Week 12
Description
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".
Time Frame
12-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Cheng Liu, PhD
Organizational Affiliation
Tri-Service General Hospital, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital, National Defense Medical Center
City
Taipei
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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