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Updated: Sep 6, 2025
Assessing Biofilm Dispersal in Murine Wounds
Published on: August 7, 2021
Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial
Yating Wei1, Jun Wu1,2, Yuxin Chen3
1Department of Burn and Plastic Surgery, Department of Wound Repair, Shenzhen Institute of Translational Medicine, the First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong Province, China.
Objective:
To assess the safety and efficacy of antimicrobial peptide PL-5 (Peceleganan) spray in the treatment of wound infections.
Background:
Antimicrobial peptide PL-5 spray is a novel topical antimicrobial agent.
Methods:
We conducted a multicenter, open-label, randomized, controlled phase IIb clinical trial to evaluate the efficacy and safety of PL-5 spray, as compared with silver sulfadiazine, in patients with skin wound infections. The primary efficacy outcome was the clinical efficacy rate on the first day after ending the treatment (D8). The secondary efficacy outcome was the clinical efficacy rate on the fifth day posttreatment (D5), the bacteria clearance rate, and the overall efficacy rate at the mentioned 2 time points. The safety outcomes included adverse reactions and pharmacokinetic analysis posttreatment.
Results:
A total of 220 patients from 27 hospitals in China were randomly assigned to 4 groups. On D8, the efficacy rate was 100.0%, 96.7%, 96.7% for the 1‰ PL-5, 2‰ PL-5, 4‰ PL-5 groups, respectively, as compared with 87.5% for the control group. The efficacy rate among the 4 groups was significantly different ( P <0.05). On D5, the efficacy rate was 100.0%, 93.4%, 98.3% for the 1‰ PL-5, 2‰ PL-5, 4‰ PL-5 groups, respectively, as compared with 82.5% for the control group. The efficacy rate among the 4 groups was significantly different ( P <0.05). The blood concentration of PL-5 was not detectable in pharmacokinetic analysis. No severe adverse event related to the application of PL-5 was reported.
Conclusions:
Antimicrobial peptide PL-5 spray is safe and effective for the treatment of skin wound infections.
Trial Registration:
ChiCTR2000033334.
Insights
Antimicrobial peptide PL-5 spray demonstrated high efficacy and safety in treating skin wound infections. This novel topical agent showed significant improvements compared to the control group, with no severe adverse events reported.
Area of Science:
- Dermatology
- Infectious Diseases
- Pharmacology
Background:
- Novel topical antimicrobial agents are crucial for combating wound infections.
- Antimicrobial peptide PL-5 (Peceleganan) spray represents a new therapeutic option.
Purpose of the Study:
- To evaluate the safety and efficacy of PL-5 spray versus silver sulfadiazine in patients with skin wound infections.
- To assess clinical efficacy rates, bacterial clearance, and safety profiles.
Main Methods:
- A multicenter, open-label, randomized, controlled phase IIb clinical trial.
- 220 patients with skin wound infections were randomized into four groups.
- Efficacy assessed on days 5 and 8 post-treatment; safety evaluated through adverse events and pharmacokinetics.
Main Results:
- PL-5 spray achieved high clinical efficacy rates (up to 100%) on day 8 and day 5 post-treatment, significantly outperforming the control group (87.5% and 82.5%, respectively).
- Bacterial clearance rates were also favorable across PL-5 groups.
- Pharmacokinetic analysis showed undetectable blood concentrations of PL-5, and no severe adverse events were reported.
Conclusions:
- Antimicrobial peptide PL-5 spray is a safe and effective treatment for skin wound infections.
- The study supports PL-5 spray as a promising alternative to existing treatments.
