Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorShenyang Medical College

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

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shenyang Medical College

Lead sponsor

the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force

Collaborator