NCT05434897

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

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.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	AK3280 Cream	Active Substance: AK3280, Pharmaceutical Form:Cream, Route of Administration: External use
DRUG	Placebo cream	Active Substance: Placebo, Pharmaceutical Form: Cream, Route of Administration: External use

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2023-11-01
• First posted: 2022-06-28
• Last updated: 2022-07-06

Locations

1 site across 1 country: China