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Completed

NCT Number: NCT05271708

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fespixon cream

Drug

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.

Other names: ON101 cream

placebo cream

Drug

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 outcomes

  1. VSS total scores at Day 1 and Week 12 assessed by 3 blind evaluators

    Time frame: 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 outcomes

  1. mVSS individual scores at Day 1 and Week 12 assessed by a Principal Investigator

    Time frame: 12-week

    The mVSS scores, assessed by a Principal Investigator, changed from Day 1 to Week 12 will be used as an auxiliary evidence.

  2. Hue feature-Red values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  3. Hue feature-Green values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  4. Hue feature-Blue values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  5. CIELab-lightness values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  6. CIELab-a values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  7. CIELab-b values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  8. Textual features-Contrast (Con) values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  9. Textual features-Homogeneity (Hom) values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  10. Textual features-Correlation (Cor) values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  11. Textual features-Entropy (ENT) values via digital analysis at Day 1 and Week 12

    Time frame: 12-week

    • 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

  12. VAS (Visual Analogue Scale) score at Week 12

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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