PMID- 35223871
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220502
IS  - 2296-6870 (Electronic)
IS  - 2296-6870 (Linking)
VI  - 6
IP  - 3
DP  - 2021 Sep-Dec
TI  - Impact of Parallel Topical Treatment with Nadifloxacin and Adapalene on Acne 
      Vulgaris Severity and Quality of Life: A Prospective, Uncontrolled, Multicentric, 
      Noninterventional Study.
PG  - 158-171
LID - 10.1159/000520447 [doi]
AB  - INTRODUCTION: Daily parallel application of adapalene and nadifloxacin has been 
      determined to be effective and well tolerated in patients with acne vulgaris in 
      randomized, controlled clinical studies. Here, the authors report the results 
      from a large, prospective, uncontrolled, multicentric, noninterventional study 
      under real-life conditions in Germany. The effect of treatment on acne severity, 
      safety, and, for the first time, health-related quality of life (HRQoL) was 
      investigated. METHODS: Of the 292 patients (safety collective: 231 adults, 61 
      adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds 
      Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 
      adolescents) were treated with adapalene 0.1% cream or gel and nadifloxacin 1% 
      cream for the defined minimum of 28 days. Patients were evaluated for acne 
      severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and 
      safety. RESULTS: After the median treatment duration of 37 and 38 days (adults 
      and adolescents, respectively), 93.4% and 85.0% of adults and adolescents, 
      respectively, exhibited a sustained decrease in acne severity. The LRAG decreased 
      by at least 3 scores in 29.1% and 24.6% of female and male adults, respectively. 
      HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median 
      improvement in the Dermatology Life Quality Index scores per patient of 3.0 
      [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children's 
      Dermatology Life Quality Index). Female adults were more impaired in terms of 
      HRQoL compared to male adults. The 2 best overall efficacy ratings were provided 
      by physicians in 79.3% and 69.5% and by patients in 68.5% and 58.3% of adult and 
      adolescent cases, respectively. The treatment was well tolerated, as reflected in 
      the low number of 9 mild adverse events (AEs), all of which resolved without 
      treatment. However, 4 patients terminated the study prematurely due to AEs. 
      CONCLUSION: In this study, the parallel use of adapalene and nadifloxacin for at 
      least 5 weeks resulted in a rapid improvement in acne severity, an increase in 
      HRQoL, and a good safety profile. Therefore, it represents a promising treatment 
      option that offers the possibility of flexible therapy adjustment.
CI  - Copyright (c) 2021 by S. Karger AG, Basel.
FAU - Neumeister, Claudia
AU  - Neumeister C
AD  - Department of Medical Science/Research & Development, Clinical Research, Dr. 
      Pfleger Arzneimittel GmbH, Bamberg, Germany.
FAU - Bodeker, Rolf-Hasso
AU  - Bodeker RH
AD  - TransMit Project Area for Medical Statistics, Justus Liebig University, Giessen, 
      Germany.
FAU - Schwantes, Ulrich
AU  - Schwantes U
AD  - Department of Medical Science/Research & Development, Clinical Research, Dr. 
      Pfleger Arzneimittel GmbH, Bamberg, Germany.
FAU - Borelli, Claudia
AU  - Borelli C
AD  - Unit of Aesthetic Dermatology and Laser, Department of Dermatology, Eberhard 
      Karls University, Tubingen, Germany.
LA  - eng
PT  - Journal Article
DEP - 20211220
PL  - Switzerland
TA  - Biomed Hub
JT  - Biomedicine hub
JID - 101692630
PMC - PMC8832211
OTO - NOTNLM
OT  - Adapalene
OT  - Nadifloxacin
OT  - Quality of life
OT  - Severity of acne
OT  - Tolerability
COIS- Claudia Neumeister is an employee and Ulrich Schwantes is a former employee of 
      Dr. Pfleger Arzneimittel GmbH. Rolf-Hasso Bodeker performed statistical planning 
      and analysis, funded by Dr. Pfleger Arzneimittel GmbH. Claudia Borelli received 
      payment from Dr. Pfleger Arzneimittel GmbH for advisory services as regards the 
      study design, results, and writing in the context of this study.
EDAT- 2022/03/01 06:00
MHDA- 2022/03/01 06:01
PMCR- 2021/12/20
CRDT- 2022/02/28 05:39
PHST- 2021/02/24 00:00 [received]
PHST- 2021/10/23 00:00 [accepted]
PHST- 2022/02/28 05:39 [entrez]
PHST- 2022/03/01 06:00 [pubmed]
PHST- 2022/03/01 06:01 [medline]
PHST- 2021/12/20 00:00 [pmc-release]
AID - bmh-0006-0158 [pii]
AID - 10.1159/000520447 [doi]
PST - epublish
SO  - Biomed Hub. 2021 Dec 20;6(3):158-171. doi: 10.1159/000520447. eCollection 2021 
      Sep-Dec.