DOI: 10.5061/dryad.12jm63z3t
title: Therapeutic use of cold atmospheric plasma for the treatment of mild acne papulopustulosa - a randomised controlled, double-blind pilot study

description: Acne is a common disease worldwide, predominantly occurring in teenagers.
 New treatment methods are of interest to circumvent prevalent challenges
 like antibiotic resistance and local adverse effects. Cold atmospheric
 plasma (CAP) is a well-tolerated, physical treatment that is well
 established in the treatment of chronic wounds since it provides
 bactericidal and wound healing properties. Our aim was to evaluate whether
 CAP is an effective add-on therapy for patients with mild acne
 papulopustulosa in a randomised controlled, double-blind pilot study to
 reduce total inflammatory lesion count (TILC), including papules and
 pustules, and improve Investigator Global Acne (IGA) score. The secondary
 endpoints were changes of sebum levels and Cutibacterium acnes
 colonization via total porphyrin count (TPC), improvement of quality of
 life via Acne Quality of Life questionnaire (Acne-QOL), and adverse events
 (AE). Forty patients were randomised into two groups of 20 patients. The
 endpoint of the treatment was at six weeks, and follow-up at week ten.
 Both groups applied daily adapalene cream 0.1% and received weekly
 skin-cleansing by a physician. One half received weekly facial
 CAP-treatments with a CAP-device, while the other half received weekly
 placebo-device application. TILC, IGA, sebumetry, TPC, and AE were
 assessed at baseline, endpoint, and follow-up. Acne-QOL was assessed at
 baseline and endpoint. From baseline to endpoint, TILC and IGA mean values
 showed greater improvement in the verum group compared to the control
 group (p = 0.07 and p &lt; 0.001, respectively). Comparing baseline
 and follow-up, a stronger improvement was observed only for IGA (p =
 0.006), but not for TILC (p = 0.408).** Also, sebum and TPC levels, as
 well as Acne-QOL, decreased more in the verum group during treatment. AE
 cases were less frequent in the in verum group, with no serious AE
 occurring in general (all p&lt; 0.005). CAP proved to be an efficient
 and well-tolerated add-on therapy for mild acne papulopustulosa by
 improving all endpoint outcomes better in verum than in
 control. Studies with longer treatment periods and greater
 cohorts are needed to further elucidate the impact of CAP on acne.
description: The dataset in the folder
 <strong>"Raw_images_files_of_measurements_Dryad"</strong> consists of files of 40 participants resulting from their visits during the interventional trial from baseline, post-treatment at week 6, until follow-up at week 10. The file data includes screen-photographs to document measurements during visits of: -Sebumetry measurements (“Sebumeter-SM 815” by Courage+Khazaka electronic GmbH <sup>®</sup>, Germany) consisting of 5 measurement areas (4 in one measurement graph and the fifth one on the next image due to software settings) from the mentalis region, right cheek, right forehead, left forehead, left cheek -Fluorescence signaling camera images (“Visiopor PP 34“ by Courage+Khazaka electronic GmbH <sup>®</sup>, Germany) consisting of 5 measurement areas from the mentalis region, right cheek, right forehead, left forehead, left cheek The <strong>CAP_acne.html</strong> file was created and exported with the software "R Markdown"<sup>®</sup>
description: # Therapeutic use of cold atmospheric plasma for the treatment of mild
 acne papulopustulosa - a randomised controlled, double-blind pilot study
 [https://doi.org/10.5061/dryad.12jm63z3t](https://doi.org/10.5061/dryad.12jm63z3t) The dataset is part of a clinical trial aiming to explore a modern treatment approach for acne papulopustulosa using cold atmospheric plasma. The endpoints measured are assessed by blinded lesion assessment, adverse event recording, and hard data measurements in the form of sebumetry and fluorescence signal measurement. ## Description of the data and file structure The data in the folder **"Raw_images_files_of_measurements_Dryad.zip"** is arranged in 40 files, each representing one participant. Visits are numbered from baseline, post-treatment (week 6), and follow-up (week 10). Each participant´s file consists of two further sub-files: 1.) Sebumetry measurements (“Sebumeter-SM 815” by Courage+Khazaka electronic GmbH®, Germany) reflecting sebum levels in the area. They consist of 5 measurement areas (4 in one measurement graph and the fifth one on the next image due to software settings). Each image file is available in the original file and a copy underneath with its anatomic description of the order from left to right: M = mentalis region, RC = right cheek, RF = right forehead, LF = left forehead, LF = left cheek. 2.) Fluorescence camera images (“Visiopor PP 34“ by Courage+Khazaka electronic GmbH®, Germany) reflecting porphyrin metabolism of *Cutibacterium acnes*, consisting of 5 measurement areas. Each image file is available in the original file and a copy underneath with its anatomic description of the order from left to right: M = mentalis region, RC = right cheek, RF = right forehead, LF = left forehead, LF = left cheek. The file **"CAP_acne.html"** contains all relevant statistical information, including methods, data, and graphs, organized into: *Preliminary remarks, Experimental design and dependent measures including:* *Design, Sample, Procedure, Measures and measurement points, Statistical analyses, Data and Demographics* -Measurements for the co-primary endpoints "TILC" (Total inflammatory lesion count) and "IGA" (Investigator global acne) score, and the secondary endpoints, including "Sebumetry", "TPC" (Total porphyrin count), and "PSV" (Porphyrin surface value) include: *Figures, Statistical analyses, Mixed ANOVA: Pre (Baseline) vs. Post (Endpoint) Comparison, Mixed ANOVA: Pre (Baseline) vs. Follow-Up-Comparison, Linear Mixed Effects Model: Pre (Baseline) vs. Post (Endpoint) Comparison, and Linear Mixed Effects Model: Pre (Baseline) vs. Follow-Up-Comparison* -For the secondary endpoint of "Acne-QOL" (Acne quality of life) questionnaire are included:  *Figures, Statistical analyses, Mixed ANOVA, Pre (Baseline) vs. Post (Endpoint) Comparison, and Linear Mixed Effects Model: Pre (Baseline) vs. Post (Endpoint) Comparison.* Finally, the last secondary endpoint "Adverse events" contains: *Figures and statistical analyses*