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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active CAP therapy
DeviceThe 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.
sham CAP therapy
Devicethe 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.
standard care based on the JAAD acne guidelines
Other interventionthe group will receive standard care based on the JAAD acne guidelines
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: the CAP treatment groupActive comparator 2 interventions
Group B: the placebo groupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
The difference in lesion clearance rate change between the CAP treatment group and the placebo group.
Time frame
Baseline and up to 6 weeks after randomisationSecondary outcomes
1
The difference between the two groups in time from randomisation to achieving 75% and 50% lesion clearance rates.
Time frame
Baseline and up to 6 weeks after randomisation2
The difference in change in quality of life (QoL) as measured by the QoL-acne questionnaire before and after treatment between the two groups.
Time frame
Baseline and 6 weeks after randomisationOther outcomes
1
The difference between the two groups in the incidence of the composite endpoint of erythema, edema, burning sensation, pruritus, exudation, desquamation, and scabbing.
Time frame
1 week, weeks 2-6 after randomisation, and 1, 2, and 3 months after the end of treatment2
The difference between the two groups in the incidence of lesion exacerbation.
Time frame
1, 2, and 3 months after the end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shenyang Medical College
Lead sponsor
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Collaborator
Source ClinicalTrials.gov