About this trial
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.
Eligibility criteria
Qualifiers
Aged 18-40 years;
Clinically diagnosed with acne vulgaris, with moderate to severe disease (Pillsbury grade III or IV, lesion count ≥50);
Will agree to use effective contraception during the treatment period;
Will sign a written informed consent form.
Disqualifiers
Pregnant or breastfeeding women;
Known allergy to any active component of CAP;
Use of systemic antibiotics within 4 weeks prior to enrollment;
Presence of dyslipidemia or other severe systemic diseases;
Trial design
Treatments tested in this trial
- Active CAP therapy
- sham CAP therapy
- standard care based on the JAAD acne guidelines
Treatment groups
Sponsors and collaborators
Shenyang Medical College
Lead sponsor
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Collaborator