Cold atmospheric plasma treatment for moderate-to-severe acne
Official title: Efficacy and Safety of Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris: a Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial
Run by Shenyang Medical College · NCT07056673 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Shenyang Medical College Academic / other |
| Locations | 1 site (Luoyang, Henan) |
| Status | Recruiting |
| Started | July 26, 2025 |
| Main results expected | July 30, 2026 |
| Study ends | December 20, 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07056673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: lye9901@163.com
- Phone: 86-24-62215130
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.