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Cream could stop raised scars from growing back after removal

NCT ID NCT05434897

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether AK3280 cream can prevent hypertrophic scars from coming back after they are surgically removed. About 30 adults with raised scars (not on the face or upper neck) will receive either the active cream or a placebo on different parts of the scar. Researchers will monitor safety and check for scar regrowth over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK3280 cream
What this could lead to
If it works, this cream could help prevent raised scars from coming back after surgical removal, improving appearance and reducing discomfort.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply to everyone. The cream may cause skin irritation or not prevent scarring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Jul 2022

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

Cicatrix, Hypertrophic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shanghai Ninth People's Hospital,Shanghal JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200011, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.