Actively Recruiting
Efficacy and Safety of Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris: a Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial
Led by Shenyang Medical College · Updated on 2026-01-02
220
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
Sponsors
S
Shenyang Medical College
Lead Sponsor
T
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of cold atmospheric plasma (CAP) therapy for people with moderate-to-severe acne vulgaris, a common chronic skin condition with complex causes and limited treatment options. This condition involves inflammation and overgrowth of certain bacteria, leading to various skin lesions. Current treatments can have side effects or resistance issues, so this study aims to test two new CAP devices designed to offer antimicrobial and skin-healing benefits as an innovative alternative. Participants will be randomly assigned to either a CAP treatment group or a placebo group. Those in the CAP group will receive up to six weekly sessions of CAP therapy using two specially designed devices to target different facial areas, with treatment stopping early if acne clears completely. The placebo group will receive sham CAP therapy that simulates the treatment without producing plasma. Both groups will also receive standard care based on established acne guidelines. During the study, participants will be monitored for changes in acne lesion clearance rates over six weeks, quality of life improvements through questionnaires, and time to achieve significant lesion reduction. Researchers will assess safety and treatment effects through clinical evaluations. The study will last six weeks after randomization, providing detailed follow-up and comparison between CAP therapy and placebo in managing moderate-to-severe acne vulgaris.
CONDITIONS
Brief Title
Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-40 years
- Clinically diagnosed with moderate to severe acne vulgaris (Pillsbury grade III or IV, lesion count ≥50)
- Agree to use effective contraception during the treatment period
- Willing to sign a written informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Known allergy to any active component of cold atmospheric plasma
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive six sessions of cold atmospheric plasma (CAP) therapy or sham therapy once weekly for six consecutive weeks. Treatment may stop early if complete clearance of facial acne is achieved before all six sessions.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Luoyang, Henan, China
Actively Recruiting
Research Team
Y
Yun-En Liu, MD
L
Lin Tao, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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