Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study
NCT ID: NCT07056673
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
220 participants
INTERVENTIONAL
2025-07-26
2026-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
NCT02759900
Safety Study of Plasma Treatment System to Treat Back Acne
NCT01662349
Evaluate the Efficacy and Safety of Intense Pulsed Light Filters Combined With Oral Medication in the Treatment of Acne
NCT04433143
Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris
NCT04213638
A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
NCT02537483
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Current therapeutic strategies primarily target reduction of inflammation, sebum production, and microbial load. The mainstays of topical therapy are antibiotics, benzoyl peroxide, and retinoids. For moderate-to-severe cases, oral antibiotics such as minocycline and doxycycline are widely used, and oral isotretinoin remains the cornerstone for severe and refractory disease. In patients with underlying hormonal disturbances, combined oestrogen/progestin therapy may be beneficial. Nevertheless, the long-term use of systemic antibiotics is associated with potential side effects, increasing antimicrobial resistance, and limited efficacy in some patients. Isotretinoin, while highly effective, can be contraindicated or poorly tolerated due to its teratogenicity and adverse effect profile. These challenges underscore the need for innovative and alternative therapeutic approaches, particularly for patients with moderate-to-severe disease, contraindications, or treatment resistance.
Cold atmospheric plasma (CAP) has recently emerged as a novel technology in wound healing and aesthetic dermatology. CAP generates a range of reactive oxygen and nitrogen species (RONS) via glow discharge at atmospheric pressure, producing strong oxidative effects that can denature and coagulate bacterial proteins, disrupt cell membranes, and induce apoptosis of pathogenic microorganisms. In addition to its antimicrobial properties, CAP stimulates local microcirculation, enhances nutrient absorption, accelerates collagen synthesis, and promotes tissue regeneration and wound healing. CAP has been approved by the US FDA since 2008 for use in a variety of dermatological indications, including acne scars, wrinkles, superficial skin lesions, actinic keratosis, viral warts, and seborrheic keratosis. Its broad-spectrum effects offer both anti-inflammatory and skin-rejuvenating benefits, with a favourable safety profile and good patient tolerability.
Although CAP holds promise as a therapeutic modality, its application in the management of acne vulgaris, particularly moderate-to-severe cases, remains underexplored. The high cost of CAP devices and limited availability in specialised dermatology centres have restricted its widespread adoption, and robust clinical data are still lacking. In a prospective study by Wasinee et al. (Mae Fah Luang University, Thailand), weekly CAP-assisted treatment over six weeks in 31 volunteers with mild-to-moderate acne led to approximately 75% reduction in lesion count, with the greatest improvement observed in inflammatory lesions. Most adverse events were mild, including transient dryness and superficial exfoliation. Arisi et al. also reported improvements in two young patients with mild-to-moderate facial acne following CAP treatment, as assessed by lesion count, sebum output, and transepidermal water loss, with no reported adverse effects. However, data on the use of CAP for moderate-to-severe acne vulgaris-where clinical management is most challenging-are particularly scarce. To date, there have been no large, randomised controlled trials specifically evaluating CAP in this population.
Given these gaps, CAP represents a potentially innovative and adjunctive therapeutic approach for moderate-to-severe acne vulgaris, particularly in cases refractory to or unsuitable for standard treatments. In this study, we combine two self-developed CAP devices to capitalise on their respective advantages, enabling personalised and precise coverage of diverse lesion sites. This strategy aims to maximise CAP's antimicrobial and wound-healing mechanisms, and to provide robust evidence regarding its safety and efficacy in the management of moderate-to-severe acne vulgaris.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
the CAP treatment group
Active CAP therapy
The 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.
standard care based on the JAAD acne guidelines
the group will receive standard care based on the JAAD acne guidelines
the placebo group
sham CAP therapy
the 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
the group will receive standard care based on the JAAD acne guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active CAP therapy
The 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
the 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
the group will receive standard care based on the JAAD acne guidelines
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
UNKNOWN
Shenyang Medical College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lin Tao
MM
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yun-En Liu, MD
Role: STUDY_CHAIR
Shenyang Medical College
Lin Tao, MM
Role: PRINCIPAL_INVESTIGATOR
Shenyang Medical College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Luoyang, Henan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAP630
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.