Ann Dermatol.  2014 Aug;26(4):462-468. 10.5021/ad.2014.26.4.462.

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

• Ehmann L
• Reinholz M
• Maier T
• Lang M
• Wollenberg A

• KMID: 2265586
• DOI: http://doi.org/10.5021/ad.2014.26.4.462

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.

Keyword

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

MeSH Terms

Dermatitis, Perioral*
Humans
Pruritus
Skin
Skin Diseases
Surveys and Questionnaires

Figure

• 

  Fig. 1 Clinical improvement of perioral dermatitis with a soothing fluid. A patient with moderate perioral dermatitis (POD). (A) Before (POD severity index [PODSI] 5) and (B) after 8 weeks of topical treatment (PODSI 0) with a soothing fluid.

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  Fig. 2 Change of the objective symptoms of perioral dermatitis (POD) during the POD severity index (PODSI) trial. Change of the objective signs of POD during 8 weeks of topical soothing fluid treatment in 39 patients. (A) Change of the PODSI score7, (B) change of the erythema component of PODSI, (C) change of the popular component of PODSI, (D) change of the squamous component of PODSI. **Significance value of p<0.01, ***significance value of p<0.0001.

• 

  Fig. 3 Change in the subjective symptoms of perioral dermatitis (POD) during during the POD severity index trial. Change in the subjective symptoms of perioral dermatitis during 8 weeks of topical soothing fluid treatment in 39 patients. (A) Change in the overall disease severity perception (visual analogue scale [VAS]), (B) change in itch perception (VAS), (C) change in perception of skin distension (VAS), (D) change in appearance as a subjective impression (VAS). *Significance value of p<0.05, **significance value of p<0.01, ***significance value of p<0.0001. ns: not significant.

• 

  Fig. 4 Subgroup analysis of patients with nonatopic perioral dermatitis (POD), clinical improvement correlated with the amount of fluid use, and comparison with a historical control group. (A) Patients with nonatopic POD showed a tendency to improve faster and better with the soothing fluid than patients with POD having an atopic diathesis (p=0.7). (B) Individual improvement of the POD severity index (PODSI) score in 39 patients plotted against the individual amount of soothing fluid (g) used during the 8-week study period. R2=0.08389. (C) Time course of PODSI in 39 patients with POD treated for 8 weeks with a soothing fluid, as well as a historical control of 20 patients treated for 4 weeks with a cream base and untreated for another 4 weeks8. There was better improvement with the soothing fluid; however, the differences observed were not significant. Comparison with historical data from Oppel et al.8 showed that the soothing fluid has nearly the same positive effect on POD as pimecrolimus cream (1%) after 4 weeks of treatment.

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