Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea
Received 14 June 2014
Accepted for publication 24 July 2014
Published 24 October 2014 Volume 2014:7 Pages 275—283
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Jeffrey Weinberg
Adele Sparavigna, Beatrice Tenconi, Ileana De Ponti
Derming Srl, Monza, Italy
Background: Rosacea is a common, incurable skin barrier disorder characterized by relapses and remissions.
Purpose: To evaluate the efficacy of Farmaka Rosacea Cream (FRC), a novel topical formulation for rosacea.
Methods: This single-center, open-label pilot study comprised a single-dose substudy in 20 healthy subjects and a long-term, repeat-dose substudy in 22 subjects with rosacea. The 2-hour, controlled, single-dose substudy assessed the soothing and reepithelialization properties of FRC after stripping-induced erythema based on the erythema index, transepidermal water loss, skin hydration, and clinical assessments of erythema. In the long-term substudy, subjects applied FRC twice daily for 8 weeks. Clinical assessments included vascular and pigmentary homogeneity and erythema and hemoglobin indices. Subjects completed questionnaires to assess FRC efficacy and cosmetic acceptability.
Results: Greater reductions were seen in FRC-treated areas compared with untreated areas for the erythema index (-16% versus -8%; P<0.001) and mean transepidermal water loss (-35.8% versus -10.1%; P<0.001) 30 minutes after stripping. Significant improvements over untreated areas were maintained 2 hours after stripping. Skin hydration and clinical erythema assessments also indicated that FRC soothed rosacea symptoms and promoted skin reepithelialization. Erythema and hemoglobin indices were significantly reduced from baseline after 4 and 8 weeks of treatment. Clinically assessed parameters were significantly improved following FRC application. Subjects assessed FRC positively.
Conclusion: Improvement of rosacea symptoms was noted with FRC application. The main film-forming ingredients of FRC (trehalose, cholesterol, ceramide, and fatty acids), combined with other soothing and calming ingredients and ultraviolet filters, could explain its efficacy.
Keywords: rosacea, erythema, skin hydration, re-epithelialization
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