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Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study

NCT07056673 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-01-02

No results posted yet for this study

Summary

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.

Conditions

  • Acne Vulgaris

Interventions

DEVICE

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.

DEVICE

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.

OTHER

standard care based on the JAAD acne guidelines

the group will receive standard care based on the JAAD acne guidelines

Sponsors & Collaborators

  • the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force

    collaborator UNKNOWN

  • Shenyang Medical College

    lead OTHER

Principal Investigators

  • Lin Tao, MM · Shenyang Medical College

  • Yun-En Liu, MD · Shenyang Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-26
Primary Completion
2026-07-30
Completion
2026-12-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07056673 on ClinicalTrials.gov