Cold atmospheric plasma treatment for moderate-to-severe acne

Efficacy and Safety of Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris: a Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial

This trial will test two cold atmospheric plasma devices to see if they safely reduce acne in adults aged 18–40 with moderate-to-severe acne.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Shenyang Medical College (Academic / other)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT07056673 on ClinicalTrials.gov

What this trial studies

Participants will be assigned to receive one of two self-developed cold atmospheric plasma (CAP) devices, a sham CAP procedure, or standard care per JAAD acne guidelines to compare outcomes. Treatments and follow-up visits will take place at a single center in Luoyang, Henan, with efficacy measured by lesion counts and severity scales and safety monitored by adverse event reporting. Key exclusions include pregnancy or breastfeeding, recent systemic antibiotic use, known CAP allergy, dyslipidemia, or other serious systemic illnesses, and recent participation in other trials. The trial aims to compare lesion reduction and tolerability between active CAP, sham treatment, and guideline-directed therapy.

Who should consider this trial

Good fit: Adults 18–40 years old with clinically diagnosed moderate-to-severe acne (Pillsbury grade III or IV, lesion count ≥50) who agree to use effective contraception and provide informed consent.

Not a fit: Individuals who are pregnant or breastfeeding, allergic to CAP components, recently used systemic antibiotics, have dyslipidemia or other severe systemic disease, or are recently enrolled in another trial are unlikely to qualify or benefit from participation.

Why it matters

Potential benefit: If successful, CAP could offer a topical, non-antibiotic option that reduces acne lesions with fewer systemic side effects than current oral therapies.

How similar studies have performed: Preliminary dermatology studies report promising antimicrobial and tissue-regenerative effects of CAP, but high-quality clinical evidence specifically for moderate-to-severe acne remains limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Luoyang, Henan

• the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force — Luoyang, Henan, China (Recruiting)

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD

Conditions Acne Vulgaris; Acne vulgaris; Cold atmospheric plasma