Clinical trial NCT05271708: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scar
Keywords: Fespixon
Thyroidectomy
caesarean section
Scar
ON101
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators
timeFrame: 12-week
Secondary outcomes:
measure: mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator
timeFrame: 12-week
measure: Hue feature-Red values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: Hue feature-Green values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: Hue feature-Blue values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: CIELab-lightness values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: CIELab-a values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: CIELab-b values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12
timeFrame: 12-week
measure: VAS (Visual Analogue Scale) score at Week 12
timeFrame: 12-week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center
name: Shao-Cheng Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: