A Study to Evaluate the Safety, Tolerability and Efficacy of AK3280 Cream on Hypertrophic Scar (NCT05434897) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate the Safety, Tolerability and Efficacy of AK3280 Cream on Hypertrophic Scar
China30 participantsStarted 2022-07-08
Plain-language 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 cicatrectomy in Patients with Hypertrophic Scar in China.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 hemo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of adverse events(AE)/ serious adverse events (SAEs)
Timeframe: Up to 14 weeks
2
Number of participants with abnormal Skin Examination
Timeframe: Up to 14 weeks
3
Number of participants with abnormal vital signs
Timeframe: Up to 14 weeks
4
Number of participants with abnormal Physical examination findings
Timeframe: Up to 14 weeks
5
Number of participants with abnormal 12-lead ECG readings
Timeframe: Up to 14 weeks
6
Number of participants with abnormal laboratory test results