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Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study
Sponsor: Shenyang Medical College
Summary
Acne vulgaris is a common, chronic inflammatory skin disease with complex pathogenesis and limited therapeutic options, especially for moderate-to-severe cases. Standard treatments-including topical and oral agents-are often constrained by side effects, antimicrobial resistance, and treatment resistance. Cold atmospheric plasma (CAP), a novel technology that generates reactive oxygen and nitrogen species, has demonstrated antimicrobial and tissue-regenerative properties in dermatology, but robust clinical evidence in acne management remains scarce. Existing data suggest promising efficacy and safety, yet its use in moderate-to-severe acne vulgaris has not been adequately investigated. This study aims to evaluate the efficacy and safety of two self-developed CAP devices as a potential innovative therapy for moderate-to-severe acne vulgaris.
Official title: Efficacy and Safety of Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris: a Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2025-07-26
Completion Date
2026-12-20
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
Active CAP therapy
The patients in the CAP group will receive six sessions of CAP treatment, administered once weekly for six consecutive weeks. If complete clearance of facial acne is achieved before all six sessions, CAP treatment will be discontinued early. For device selection, the CAP patch trauma therapy device (CAP-PTTD) will be used for lesions located on relatively flat areas of the face. In cases of lesions on areas with greater anatomical curvature (eg, the mandibular angle or near the tragus), the CAP jet trauma therapy device (CAP-JTTD) will be used in combination.
sham CAP therapy
the device will be operated with the plasma-generating field disabled, so that no plasma will be produced. Only environmental cues such as sound will be simulated to ensure blinding.
standard care based on the JAAD acne guidelines
the group will receive standard care based on the JAAD acne guidelines
Locations (1)
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Luoyang, Henan, China