Hypertrophic ScarPhase 1/2NCT05434897

A Study to Evaluate the Safety, Tolerability and Efficacy of AK3280 Cream on Hypertrophic Scar

A Phase 1/2 study testing AK3280 Cream in people with Hypertrophic Scar, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Hypertrophic Scar
What is being tested?: AK3280 Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteChina
Study dates: 8 Jul 2022to 18 Jul 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Ninth People's Hospital,Shanghal JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo Self-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Preventive Efficacy of AK3280 Cream After Cicatrectomy in Patients With Hypertrophic Scar in China.

Read the 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 for 2%, 4%, 8% doses of AK3287 （AK3280 cream） in turn, and 10 participants in each cohort. Participants in every cohort will receive cicatrectomy on day -5, and their incisions will be divided into 3 parts with equal length after length measurement on day 1, named S1, S2, S3. S1 is proximal, and S3 is distal. AK3280 cream （AK3287 ） or placebo will topically administrated to S1 or S3 randomly, twice a day (BID). In this study, S1 and S3 paired, placebo self-control design will be adopted.

The study includes a 4-week screening period, a 12-week drug observation period, and a 2-week safety follow-up period.

Conditions: Hypertrophic Scar
Being tested: AK3280 Cream, Placebo cream
Medical subject headings: Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AK3280 CreamDrug
Also called AK3287
Active Substance: AK3280, Pharmaceutical Form:Cream, Route of Administration: External use
Placebo creamDrug
Active Substance: Placebo, Pharmaceutical Form: Cream, Route of Administration: External use

Study groups in NCT05434897
Study group	Role	What they receive
2% dose AK3280 cream	Experimental	After the 4-week screening period, Eligible subjects will be administered daily 2% dose AK3280 cream b.i.d. for 12weeks. Receives: Drug: AK3280 Cream
4% dose AK3280 cream	Experimental	After the 4-week screening period, Eligible subjects will be administered daily 4% dose AK3280 cream b.i.d. for 12weeks. Receives: Drug: AK3280 Cream
8% dose AK3280 cream	Experimental	After the 4-week screening period, Eligible subjects will be administered daily 8% dose AK3280 cream b.i.d. for 12weeks. Receives: Drug: AK3280 Cream
Placebo cream	Active comparator	The same subject will be randomized to receive topical administration of AK3280 cream or placebo cream at S1 and S3, respectively. Receives: Drug: Placebo cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of adverse events（AE）/ serious adverse events (SAEs)
Adverse Events occurring from day1 to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 14 weeks
Number of participants with abnormal Skin Examination
The skin examination should be performed under sufficient light and at room temperature , including skin lesion, inflammation, allergy, Scar hyperplasia.
Measured: Up to 14 weeks
Number of participants with abnormal vital signs
Vital signs: include pulse, respiration, body temperature and blood pressure
Measured: Up to 14 weeks
Number of participants with abnormal Physical examination findings
Physical examination ： include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Measured: Up to 14 weeks
Number of participants with abnormal 12-lead ECG readings
Measured: Up to 14 weeks
Number of participants with abnormal laboratory test results
Laboratory tests：include blood routine examination， blood biochemistry ，urine routine test and coagulation function
Measured: Up to 14 weeks

Secondary outcomes (16)

Within 12 weeks of topical administration, the proportion of scar hyperplasia/recurrence compared in S1 and S3 segment
There are 4 items in the VSS scale（Vancouver Scar Scale） , Vascularity、 Pigmentation、 Pliability and Height. A total of 13 points, with minimum 0 indicating normal skin and maximum 13 indicating the most scarring and worst appearance. Two trained and skilled physicians are required to objectively evaluate the scar of all subjects. The scar was observed after pressing with a special glass slide for 2 seconds, and the average score of both was used as the final score of VSS to reduce subjective bias.
Scar hyperplasia/recurrence was defined as the Height item score of the VSS scale ≥2.
If two investigators had different scores in Height item, for safety, the higher score would be final result.
Measured: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of VSS （Vancouver Scar Scale ） total score compared in S1 and S3 segment from baseline
There are 4 items in the VSS scale（Vancouver Scar Scale） , Vascularity、 Pigmentation、 Pliability and Height. A total of 13 points, with minimum 0 indicating normal skin and maximum 13 indicating the most scarring and worst appearance. Two trained and skilled physicians are required to objectively evaluate the scar of all subjects. The scar was observed after pressing with a special glass slide for 2 seconds, and the average score of both was used as the final score of VSS to reduce subjective bias.
Measured: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of mean thickness by 3D photography compared in S1 and S3 segment from baseline
Taking 5 points in each segment can automatically get the thickness of each point by 3D photography and calculate the average thickness.
Measured: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of surface area per centimeter by 3D photography compared in S1 and S3 segment from baseline
Surface area can be obtained directly by 3D photography，then calculate the surface area per centimeter.
Measured: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of volume per centimeter by 3D photography compared in S1 and S3 segment from baseline
Volume can be obtained directly by 3D photography，then calculate the volume per centimeter.
Measured: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of blood flow in laser speckle imaging system compared in S1 and S3 segment from baseline
Blood perfusion of capillary of scar, para-scar and normal tissue will be tested by laser speckle imaging system to evaluate scar recurrence compared S1 with S3.
Measured: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Cmax (Maximum observed concentration) of AK3280 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
Ctrough (trough level concentration) of AK3280 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
Tmax (Time of peak plasma concentration) of AK3280 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
AUC0-t (Area under the concentration-time curve from time zero to the last measurable concentration ) of AK3280 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
CL/F (apparent clearance) of AK3280 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
Cmax of AK3280 M2 after topical administration of AK3280 onitment.
Four metabolites (M1-M4) were detected in human plasma collected after oral administration of AK3280. M2 is the most abundant metabolite circulating in the blood, also found in urine.
Measured: Up to 14 weeks
Ctrough of AK3280 M2 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
Tmax of AK3280 M2 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
AUC0-t of AK3280 M2 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks
CL/F of AK3280 M2 after topical administration of AK3280 onitment.
Measured: Up to 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202218 Jul 2023

First posted28 Jun 2022
Study start8 Jul 2022
Primary completion18 Jul 2023
Study completion18 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05434897
Sponsor's protocol ID: AK3287-2001
Status last verified: Jun 2026
First submitted: 16 Jun 2022
Last updated: 22 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertrophic Scar trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Self-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Preventive Efficacy of AK3280 Cream After Cicatrectomy in Patients With Hypertrophic Scar in China.
ClinicalTrials.gov ID: NCT05434897
Acronym / sponsor ID: AK3287-2001
Conditions: Hypertrophic Scar
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jul 2022 (actual)
Primary completion: 18 Jul 2023 (actual)
Study completion: 18 Jul 2023 (actual)
First posted: 28 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study includes a 4-week screening period, a 12-week drug observation period, and a 2-week safety follow-up period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
2% dose AK3280 cream	Experimental	Drug: AK3280 CreamAfter the 4-week screening period, Eligible subjects will be administered daily 2% dose AK3280 cream b.i.d. for 12weeks.
4% dose AK3280 cream	Experimental	Drug: AK3280 CreamAfter the 4-week screening period, Eligible subjects will be administered daily 4% dose AK3280 cream b.i.d. for 12weeks.
8% dose AK3280 cream	Experimental	Drug: AK3280 CreamAfter the 4-week screening period, Eligible subjects will be administered daily 8% dose AK3280 cream b.i.d. for 12weeks.
Placebo cream	Active comparator	Drug: Placebo creamThe same subject will be randomized to receive topical administration of AK3280 cream or placebo cream at S1 and S3, respectively.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK3280 CreamAlso: AK3287Active Substance: AK3280, Pharmaceutical Form:Cream, Route of Administration: External use	Drug	2% dose AK3280 cream, 4% dose AK3280 cream, 8% dose AK3280 cream
Placebo creamActive Substance: Placebo, Pharmaceutical Form: Cream, Route of Administration: External use	Drug	Placebo cream

Primary outcome

Assessment of adverse events（AE）/ serious adverse events (SAEs)
Time frame: Up to 14 weeks
Adverse Events occurring from day1 to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0.
Number of participants with abnormal Skin Examination
Time frame: Up to 14 weeks
The skin examination should be performed under sufficient light and at room temperature , including skin lesion, inflammation, allergy, Scar hyperplasia.
Number of participants with abnormal vital signs
Time frame: Up to 14 weeks
Vital signs: include pulse, respiration, body temperature and blood pressure
Number of participants with abnormal Physical examination findings
Time frame: Up to 14 weeks
Physical examination ： include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Number of participants with abnormal 12-lead ECG readings
Time frame: Up to 14 weeks
Number of participants with abnormal laboratory test results
Time frame: Up to 14 weeks
Laboratory tests：include blood routine examination， blood biochemistry ，urine routine test and coagulation function

16 secondary outcomes

Within 12 weeks of topical administration, the proportion of scar hyperplasia/recurrence compared in S1 and S3 segment
Time frame: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of VSS （Vancouver Scar Scale ） total score compared in S1 and S3 segment from baseline
Time frame: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of mean thickness by 3D photography compared in S1 and S3 segment from baseline
Time frame: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of surface area per centimeter by 3D photography compared in S1 and S3 segment from baseline
Time frame: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of volume per centimeter by 3D photography compared in S1 and S3 segment from baseline
Time frame: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Within 12 weeks of topical administration, the change of blood flow in laser speckle imaging system compared in S1 and S3 segment from baseline
Time frame: 4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)
Cmax (Maximum observed concentration) of AK3280 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
Ctrough (trough level concentration) of AK3280 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
Tmax (Time of peak plasma concentration) of AK3280 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
AUC0-t (Area under the concentration-time curve from time zero to the last measurable concentration ) of AK3280 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
CL/F (apparent clearance) of AK3280 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
Cmax of AK3280 M2 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
Ctrough of AK3280 M2 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
Tmax of AK3280 M2 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
AUC0-t of AK3280 M2 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks
CL/F of AK3280 M2 after topical administration of AK3280 onitment.
Time frame: Up to 14 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Hypertrophic Scar

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jihong Liu study director

Medical Director

Yan Wu study chair

Chief Medical Officer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK3280 Cream in people with Hypertrophic Scar, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of adverse events（AE）/ serious adverse events (SAEs) (time frame: Up to 14 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434897.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.