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Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea.

Sparavigna A, Tenconi B, De Ponti I - Clin Cosmet Investig Dermatol (2014)

Bottom Line: Clinically assessed parameters were significantly improved following FRC application.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.

View Article: PubMed Central - PubMed

Affiliation: Derming Srl, Monza, Italy.

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus

Farmaka Rosacea Cream reduces transepidermal water loss (TEWL). Mean TEWL (±0.5 standard deviations) before stripping (T0), immediately after stripping (Ti), 30 minutes after stripping (T30m), and 2 hours after stripping (T2h).Notes: *P<0.05 Ti versus T0; ***P<0.001 treated versus untreated at T30m; $P<0.05 T30m and T2h versus Ti. The numbers in brackets denote the percentage decrease in TEWL compared with Ti.
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f3-ccid-7-275: Farmaka Rosacea Cream reduces transepidermal water loss (TEWL). Mean TEWL (±0.5 standard deviations) before stripping (T0), immediately after stripping (Ti), 30 minutes after stripping (T30m), and 2 hours after stripping (T2h).Notes: *P<0.05 Ti versus T0; ***P<0.001 treated versus untreated at T30m; $P<0.05 T30m and T2h versus Ti. The numbers in brackets denote the percentage decrease in TEWL compared with Ti.

Mentions: A significant increase in TEWL compared with base-line (P<0.05) was observed at Ti for treated and untreated areas, suggesting the cutaneous barrier was damaged by skin stripping. After FRC application, TEWL was reduced by 35.8% at T30m compared with Ti (P<0.05), returning to a level comparable to baseline (T30m 5.25 g/m2/hour versus T0 4.74 g/m2/hour). This reduction was significantly greater than the reduction observed in the control area (−35.8% versus −10.1%; P<0.001). At T2h, TEWL remained low with no statistical difference from T0, whereas control areas had sustained barrier dysfunction (Figure 3).


Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea.

Sparavigna A, Tenconi B, De Ponti I - Clin Cosmet Investig Dermatol (2014)

Farmaka Rosacea Cream reduces transepidermal water loss (TEWL). Mean TEWL (±0.5 standard deviations) before stripping (T0), immediately after stripping (Ti), 30 minutes after stripping (T30m), and 2 hours after stripping (T2h).Notes: *P<0.05 Ti versus T0; ***P<0.001 treated versus untreated at T30m; $P<0.05 T30m and T2h versus Ti. The numbers in brackets denote the percentage decrease in TEWL compared with Ti.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4216025&req=5

f3-ccid-7-275: Farmaka Rosacea Cream reduces transepidermal water loss (TEWL). Mean TEWL (±0.5 standard deviations) before stripping (T0), immediately after stripping (Ti), 30 minutes after stripping (T30m), and 2 hours after stripping (T2h).Notes: *P<0.05 Ti versus T0; ***P<0.001 treated versus untreated at T30m; $P<0.05 T30m and T2h versus Ti. The numbers in brackets denote the percentage decrease in TEWL compared with Ti.
Mentions: A significant increase in TEWL compared with base-line (P<0.05) was observed at Ti for treated and untreated areas, suggesting the cutaneous barrier was damaged by skin stripping. After FRC application, TEWL was reduced by 35.8% at T30m compared with Ti (P<0.05), returning to a level comparable to baseline (T30m 5.25 g/m2/hour versus T0 4.74 g/m2/hour). This reduction was significantly greater than the reduction observed in the control area (−35.8% versus −10.1%; P<0.001). At T2h, TEWL remained low with no statistical difference from T0, whereas control areas had sustained barrier dysfunction (Figure 3).

Bottom Line: Clinically assessed parameters were significantly improved following FRC application.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.

View Article: PubMed Central - PubMed

Affiliation: Derming Srl, Monza, Italy.

ABSTRACT

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.

No MeSH data available.


Related in: MedlinePlus