Scar
Conditions
Keywords
Fespixon, Thyroidectomy, caesarean section, Scar, ON101
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.
Interventions
DRUGFespixon 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.
DRUGPlacebo 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.
Sponsors
National Defense Medical Center, Taiwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcomes (VSS score) assessors do not know which side is applied with the therapeutic ointment.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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-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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
Countries
Taiwan
Outcome results
None listed