Explore the Role of Fespixon in Linear Scar Aesthetics

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Defense Medical Center, Taiwan

Criteria

Inclusion Criteria:

1. Subjects, male or female, aged 20 to 80 years (inclusive) 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.

2. Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening and willing to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and/or who have been sterilized).

3. Subject / identified caregiver trained on the study procedures is able and willing to comply with study procedures and applicable dressing changes.

4. A signed and dated informed consent form has been obtained from the subject.

Exclusion Criteria:

1. Subjects who have previous neck or abdominal trauma or radiation therapy that will affect the surgical incision site

2. Previous medical history with chemo-therapy or targeted therapy for any reason

3. Laboratory values at Screening of:

1. Hemoglobin < 10.0 g/dL

2. White Blood Cells (WBC) < 3.0 X 109 cells/L；> 12.0 X 109 cells/L

3. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal

4. Albumin < 2.5 g/dL

5. Renal function studies [Serum Creatinine and Urea] > 3x the upper limit of normal

4. Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the Investigator, could interfere with wound healing, including but not limited to the following:

1. Current sepsis

2. Acquired immune deficiency syndrome (AIDS) or HIV positive.

5. Subject is currently receiving (i.e., within 30 days of randomization visit) or scheduled to receive any of following medication or therapies, could interfere with wound healing during the course of the study.

c. immunosuppressants (including chronic systemic corticosteroids) d. cytotoxic chemotherapy e. cytostatic therapy f. autoimmune disease therapy g. dialysis h. lower limb revascularization surgery (e.g., angioplasty, artery bypass surgery) i. growth factors j. hyperbaric oxygen therapy k. bioengineered tissue or skin substitutes l. application of topical steroids to the ulcer surface m. use of any investigational drug(s)

6. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.

7. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study