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

NCT05434897 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jihong Liu · Medical Director

  • Yan Wu · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2023-07-31
Completion
2023-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05434897 on ClinicalTrials.gov