Status:
UNKNOWN
A Study to Evaluate the Safety, Tolerability and Efficacy of AK3280 Cream on Hypertrophic Scar
Lead Sponsor:
Shanghai Ark Biopharmaceutical Co., Ltd.
Conditions:
Hypertrophic Scar
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
A randomized, double-blind, placebo self-controlled phase I/II clinical study to evaluate the safety, tolerability and preventive efficacy of different doses of AK3280 cream （AK3287 ） after cicatrecto...
Detailed Description
Thirty patients with hypertrophic scar who will scheduled for cicatrectomy and meet the all inclusion criteria and none of exclusion criteria will participate in this study. There will be 3 cohorts fo...
Eligibility Criteria
Inclusion
- 1\) Patients who sign informed consent before participating in the study.
- 2\) Patients aged between 18 and 60 (including 18 and 60).
- 3)Patients who understand and be willing to follow the study procedure and be able to complete the whole process of the study.
- 4\) Patients with visible hypertrophic scars in any location other than the face and anterior middle and upper neck caused by trauma or surgery and planned for surgical treatment.
- 5\) Patients with postoperative scar length ≥ 6 cm, and preoperative scar length ≥4cm.
- 6\) Women of childbearing age should have negative serum pregnancy test during screening period and on study day 1.
Exclusion
- 1\) Patients who were systematically treated or topically treated with corticosteroids or immunosuppressants during the 30 days prior to the screening period;
- 2\) Patients who accepted systematically chemotherapy during 30 days prior to the screening period;
- 3\) Patients whose hypertrophic scars are being locally infected, or with sepsis;
- 4\) Hypertrophic scar patients with potential keloid trend or keloid history;
- 5\) Patients with autoimmune diseases or immune insufficiency or defects
- 6)Patient with uncontrolled diabetes - HbA1c (glycosylated hemoglobin A1c) ≥ 8% ，with peripheral neuropathy, peripheral arterial atresia, or other vascular diseases;
- 7\) Patients with abnormal anticoagulation or coagulation function;
- 8\) Patients with atrophic skin diseases, rheumatism or hemopathy ;
- 9\) Patients with abnormal liver and kidney function: I. AST (Aspartate Transaminase) or ALT (Alanine Transaminase) \> the upper limit of normal, and total bilirubin \> the upper limit of normal; Ii. AST or ALT≥1.5 times of the upper limit of normal; Iii. Creatinine clearance rate\< 60mL/ min ;
- 10\) Patients with infectious diseases such as positive antibody of HBV (hepatitis B virus) , HCV (hepatitis B virus), HIV (human immunodeficiency virus) or syphilis;
- 11\) The patients or their family have a history of hypersensitivity or allergies to multiple substances, or serious atopic dermatitis, or are not suitable for participate this study by investigator's judgment;
- 12\) Patients who are currently or possibly suffering from malignant tumors;
- 13\) Patients with definite diagnosis of mental illness with irregular medication;
- 14\) Patients received any treatment that may affect wound healing, cicatrization, hemostasis or anti-coagulation, possible interactions with investigational drug within 30 days prior to randomization;
- 15\) The investigators judge that patients have safety risk, or cannot complete this study or collect all blood concentration because of patient's general condition, comorbidity or medical history, or abnormal physical examination/vital signs/laboratory tests/electrocardiogram;
- 16\) Patients who have received scar ablation or X-ray therapy within the past 6 months;
- 17\) Patients have participated in other clinical trials of medicine or devices within 30 days prior to the screening period;
- 18\) Pregnant or lactating women;
- 19\) Women and men of reproductive age who are not willing to use highly effective contraception during the study period and at least 3 months after the last administration.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05434897
Start Date
July 1 2022
End Date
November 1 2023
Last Update
July 6 2022
Active Locations (1)
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1
Shanghai Ninth People's Hospital,Shanghal JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011