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

NCT07056673 | Recruiting DMC

• 1 other identifier: CAP630
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acne vulgaris; Cold atmospheric plasma

Outcome Measures

Primary Outcomes (1)

• The difference in lesion clearance rate change between the CAP treatment group and the placebo group.

  Baseline and up to 6 weeks after randomisation

Secondary Outcomes (2)

• The difference between the two groups in time from randomisation to achieving 75% and 50% lesion clearance rates.

  Baseline and up to 6 weeks after randomisation

• The difference in change in quality of life (QoL) as measured by the QoL-acne questionnaire before and after treatment between the two groups.

  Baseline and 6 weeks after randomisation

Other Outcomes (2)

• The difference between the two groups in the incidence of the composite endpoint of erythema, edema, burning sensation, pruritus, exudation, desquamation, and scabbing.

  1 week, weeks 2-6 after randomisation, and 1, 2, and 3 months after the end of treatment

• The difference between the two groups in the incidence of lesion exacerbation.

  1, 2, and 3 months after the end of treatment

Study Arms (2)

the CAP treatment group

ACTIVE COMPARATOR

Device: Active CAP therapy; Other: standard care based on the JAAD acne guidelines

the placebo group

PLACEBO COMPARATOR

Device: sham CAP therapy; Other: standard care based on the JAAD acne guidelines

Interventions

Active CAP therapy DEVICE

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.

the CAP treatment group

sham CAP therapy DEVICE

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.

the placebo group

standard care based on the JAAD acne guidelines OTHER

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

the CAP treatment group; the placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• the 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force: collaborator
• Shenyang Medical College: lead

Study Sites (1)

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

Luoyang, Henan, China

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Lin Tao, MM

  Shenyang Medical College

  PRINCIPAL INVESTIGATOR

• Yun-En Liu, MD

  Shenyang Medical College

  STUDY CHAIR

Central Study Contacts

Yun-En Liu, MD

CONTACT

86-24-62215130; lye9901@163.com

Lin Tao, MM

CONTACT

86-18802401698; 1939908868@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: For the placebo group, 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MM

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: July 26, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)