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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 decreases both erythema and cutaneous hemoglobin indices. Mean erythema and hemoglobin index (±0.5 standard deviations) at baseline (T0), after 4 weeks of treatment (T4), and after 8 weeks of treatment (T8).Note: *P<0.05.
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f4-ccid-7-275: Farmaka Rosacea Cream decreases both erythema and cutaneous hemoglobin indices. Mean erythema and hemoglobin index (±0.5 standard deviations) at baseline (T0), after 4 weeks of treatment (T4), and after 8 weeks of treatment (T8).Note: *P<0.05.

Mentions: Compared with T0, statistically significant reductions were reported for EI (−18%; P<0.05) and skin hemoglobin (−21%; P<0.05) at T4, which were maintained for the 8 week treatment period (EI −27% and hemoglobin −34% at T8 versus T0; P<0.05) (Figure 4). A statistically significant reduction in vascular homogeneity score was observed after 4 weeks (−55% at T4 versus T0; P<0.05) and 8 weeks (−75% at T8 versus T0; P<0.05) of treatment. Video dermoscopy revealed a reduction in capillary diameter (Figure 5).


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 decreases both erythema and cutaneous hemoglobin indices. Mean erythema and hemoglobin index (±0.5 standard deviations) at baseline (T0), after 4 weeks of treatment (T4), and after 8 weeks of treatment (T8).Note: *P<0.05.
© Copyright Policy
Related In: Results  -  Collection

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

f4-ccid-7-275: Farmaka Rosacea Cream decreases both erythema and cutaneous hemoglobin indices. Mean erythema and hemoglobin index (±0.5 standard deviations) at baseline (T0), after 4 weeks of treatment (T4), and after 8 weeks of treatment (T8).Note: *P<0.05.
Mentions: Compared with T0, statistically significant reductions were reported for EI (−18%; P<0.05) and skin hemoglobin (−21%; P<0.05) at T4, which were maintained for the 8 week treatment period (EI −27% and hemoglobin −34% at T8 versus T0; P<0.05) (Figure 4). A statistically significant reduction in vascular homogeneity score was observed after 4 weeks (−55% at T4 versus T0; P<0.05) and 8 weeks (−75% at T8 versus T0; P<0.05) of treatment. Video dermoscopy revealed a reduction in capillary diameter (Figure 5).

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