title: Efficacy and Safety Results of a Drug-Free Cosmetic Fluid for Perioral Dermatitis: The Toleriane Fluide Efficacy in Perioral Dermatitis (TOLPOD) Study.
abstract: BACKGROUND
  Perioral dermatitis (POD) is a common inflammatory skin disease without standard therapy.
  
  
  OBJECTIVE
  We sought to evaluate the clinical value of a soothing fluid for the treatment of POD.
  
  
  METHODS
  We included 51 patients with POD in this 8-week clinical trial. The Toleriane Fluide Efficacy in Perioral Dermatitis (TOLPOD) study had an open-label design and involved twice-daily application of Toleriane Fluide, a soothing cosmetic fluid. Clinical assessment of POD was performed with a predefined questionnaire including the POD severity index (PODSI). Control visits were made after 4 and 8 weeks of treatment.
  
  
  RESULTS
  The results were compared with those of a historical control group treated with a vehicle cream. Patients treated with the soothing fluid showed a continuous and significant improvement of the PODSI over time. The improvement of PODSI observed with the soothing fluid was better, but not significantly better, than that observed in the historical controls. In addition, the subjective complaints of patients such as disease burden, itching, distension of the skin, and appearance improved during treatment.
  
  
  CONCLUSIONS
  A soothing fluid could be a clinically useful treatment option for POD.
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany. ; Department of Dermatology, Heinrich Heine University, Dusseldorf, Germany.
authors.forename: Laura
authors.initials: L
authors.lastname: Ehmann
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Reinholz
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Maier
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Lang
authors.affiliation: Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wollenberg
keywords: Clinical trial; Perioral dermatitis; Perioral dermatitis severity index score; Soothing fluid; Subjective severity score; Zero therapy