ACNE VULGARIS L70.0
Conditions
Interventions
Group 1: Treatment with cold plasma
Group 2: no treatment
Sponsors
IonMed Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria were age of at least 18 years, moderate papulopustular acne with lesions on both sides of the face, Investigator Global Assessment (IGA) scale score of 3 at baseline, a negative urine or serum pregnancy test in female subjects, the ability of the subject to comply with the procedures required and written informed consent. Only patients were enrolled who did not adequately respond to or did not tolerate standard acne treatments.
Exclusion criteria
Exclusion criteria: Exclusion criteria were concomitant topical or systemic acne treatments or antibiotic treatments (topical acne treatment during four weeks preceding study treatment and systemic acne treatment during eight weeks preceding study treatment), planned topical or systemic acne treatments other than plasma in the next ten weeks, nodulocystic acne, suppression of the immune system, chronic malnutrition, diabetes, asthma, participation in other clinical trial, skin diseases that might interfere with the evaluation of study treatment, psychiatric disorders, prisoners, pregnancy, lactation, active implants such as pacemakers or pulse generators or implanted cardiac defibrillators, severe internal diseases, severe ocular diseases and severe skin diseases affecting the face.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (AEs and SAEs) and efficacy of cold plasma treatment (reduction of number of acne lesions between baseline and last treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of acne lesions between baseline and 2 weeks and 4 weeks follow up. Patient satisfaction as measured with the Global Asthetic Improvement Scale (GAIS), Improvement of acne as measured with the Investigator Global Assessment (IGA). Pain (VAS) during treatment. | — |
Countries
Germany
Contacts
Public ContactSigrid Karrer
Dermatologische Klinik am Universitätsklinikum Regensburg
Outcome results
None listed