Status:
COMPLETED
Explore the Short- and Mid-term Effects of Fespixon in Scar Cosmesis Following Cervical or Abdominal Surgery
Lead Sponsor:
National Defense Medical Center, Taiwan
Conditions:
Scar
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 asses...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05271708
Start Date
January 5 2022
End Date
November 30 2022
Last Update
December 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tri-Service General Hospital, National Defense Medical Center
Taipei, Taiwan, 114