DRKS00025008
Completed
未知
Evaluation of the safety and efficacy of the BioWeld1 system in the treatment of acne vulgaris - CLP213
IonMed Ltd.0 sites34 target enrollmentApril 7, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- ACNE VULGARIS
- Sponsor
- IonMed Ltd.
- Enrollment
- 34
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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.
Outcomes
Primary Outcomes
Not specified
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