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

NCT05434897 | Unknown Phase 1

• 1 other identifier: AK3287-2001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 cicatrectomy in Patients with Hypertrophic Scar in China.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  Up to 14 weeks

• Number of participants with abnormal vital signs

  Vital signs: include pulse, respiration, body temperature and blood pressure

  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

  Up to 14 weeks

• Number of participants with abnormal 12-lead ECG readings

  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

  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

  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

  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

  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

  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

  4 weeks， 8 weeks, 12 weeks, and unscheduled visits (up to 14 weeks)

Study Arms (4)

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.

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.

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.

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.

Drug: Placebo cream

Interventions

AK3280 Cream DRUG

Active Substance: AK3280, Pharmaceutical Form:Cream, Route of Administration: External use

Also known as: AK3287

2% dose AK3280 cream; 4% dose AK3280 cream; 8% dose AK3280 cream

Placebo cream DRUG

Active Substance: Placebo, Pharmaceutical Form: Cream, Route of Administration: External use

Placebo cream

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Patients who sign informed consent before participating in the study.
• \) Patients aged between 18 and 60 (including 18 and 60).
• )Patients who understand and be willing to follow the study procedure and be able to complete the whole process of the study.
• \) 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.
• \) Patients with postoperative scar length ≥ 6 cm, and preoperative scar length ≥4cm.
• \) Women of childbearing age should have negative serum pregnancy test during screening period and on study day 1.

You may not qualify if:

• \) Patients who were systematically treated or topically treated with corticosteroids or immunosuppressants during the 30 days prior to the screening period;
• \) Patients who accepted systematically chemotherapy during 30 days prior to the screening period;
• \) Patients whose hypertrophic scars are being locally infected, or with sepsis;
• \) Hypertrophic scar patients with potential keloid trend or keloid history;
• \) Patients with autoimmune diseases or immune insufficiency or defects
• )Patient with uncontrolled diabetes - HbA1c (glycosylated hemoglobin A1c) ≥ 8% ，with peripheral neuropathy, peripheral arterial atresia, or other vascular diseases;
• \) Patients with abnormal anticoagulation or coagulation function;
• \) Patients with atrophic skin diseases, rheumatism or hemopathy ;
• \) 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 ;
• \) Patients with infectious diseases such as positive antibody of HBV (hepatitis B virus) , HCV (hepatitis B virus), HIV (human immunodeficiency virus) or syphilis;
• \) 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;
• \) Patients who are currently or possibly suffering from malignant tumors;
• \) Patients with definite diagnosis of mental illness with irregular medication;
• \) 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;
• \) 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;

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jihong Liu

  Medical Director

  STUDY DIRECTOR

• Yan Wu

  Chief Medical Officer

  STUDY CHAIR

Central Study Contacts

Minyan Guo

CONTACT

86-13651919464; nora.guo@arkbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 28, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)