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

NCT ID: NCT05271708

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Scar

Keywords

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Fespixon Thyroidectomy caesarean section Scar ON101

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and outcomes (VSS score) assessors do not know which side is applied with the therapeutic ointment.

Study Groups

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Fespixon cream

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.

Group Type EXPERIMENTAL

Fespixon cream

Intervention Type 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.

Placebo Cream

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.

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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ON101 cream

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Shao-Cheng Liu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shao-Cheng Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital, National Defense Medical Center

Locations

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Tri-Service General Hospital, National Defense Medical Center

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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B202105176L

Identifier Type: OTHER

Identifier Source: secondary_id

B202105176

Identifier Type: -

Identifier Source: org_study_id