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

National Defense Medical Center, Taiwan

Status and phase: Completed; Phase 4

Conditions: Scar

Treatments: Drug: Placebo Cream; Drug: Fespixon cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05271708

B202105176L (Other Identifier)

B202105176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Fespixon cream

Experimental group

Description:

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.

Treatment:

Drug: Fespixon cream

Placebo Cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Cream