Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study
Efficacy and Safety of Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris: a Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial
Shenyang Medical College
220 participants
Jul 26, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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;
- Participation in other clinical trials within the past 3 months or currently enrolled in another clinical trial.
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Interventions
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.
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.
the group will receive standard care based on the JAAD acne guidelines
Locations(1)
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NCT07056673