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

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271708
• Other study ID #: B202105176
• Secondary ID: B202105176L
• Status: Completed
• Phase: Phase 4
• Start date: January 5, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 30, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cicatrix
• Scar

Intervention

Drug:
• Fespixon 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.
• Placebo 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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hue feature-Red values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	Hue feature-Green values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	Hue feature-Blue values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	CIELab-lightness values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	CIELab-a values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	CIELab-b values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12	1. Using the data of Day1 as baseline, relative ? ratio represents the difference of ? ratio between Week 12 and Day1 out of baseline.; NOTE1: Relative ? ratio = (Week 12 ? ratio - Day1 ? ratio)/ Day1 ? ratio; NOTE2: Difference ratio= ? ratio = ?(scar-skin)/skin	12-week
Secondary	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