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Ann Dermatol. 2014 Aug;26(4):462-8. doi: 10.5021/ad.2014.26.4.462. Epub 2014 Jul 31.

Efficacy and Safety Results of a Drug-Free Cosmetic Fluid for Perioral Dermatitis: The Toleriane Fluide Efficacy in Perioral Dermatitis (TOLPOD) Study.

Author information

1
Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany. ; Department of Dermatology, Heinrich Heine University, Dusseldorf, Germany.
2
Department of Dermatology and Allergy, Ludwig Maximilian University, Munich, Germany.

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.

CONCLUSION:

A soothing fluid could be a clinically useful treatment option for POD.

KEYWORDS:

Clinical trial; Perioral dermatitis; Perioral dermatitis severity index score; Soothing fluid; Subjective severity score; Zero therapy

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