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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 improves vascular and pigmentary homogeneity. The mean values of the tested parameters were depicted using a “spider web” graph (Spiderming®). After 4 weeks of treatment (T4), 60% of subjects demonstrated an improvement of vascular homogeneity, while after 8 weeks of treatment (T8), a statistically significant improvement of pigmentary homogeneity was measured in 70% of the subjects (P<0.05 T0 versus T4 and T8).
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f6-ccid-7-275: Farmaka Rosacea Cream improves vascular and pigmentary homogeneity. The mean values of the tested parameters were depicted using a “spider web” graph (Spiderming®). After 4 weeks of treatment (T4), 60% of subjects demonstrated an improvement of vascular homogeneity, while after 8 weeks of treatment (T8), a statistically significant improvement of pigmentary homogeneity was measured in 70% of the subjects (P<0.05 T0 versus T4 and T8).

Mentions: The “spider web” graph (Figure 6) revealed statistically significant improvements in vascular and pigmentary homogeneity at T4 and T8. Furthermore, 60% and 70% of the subjects demonstrated an improvement in pigmentary homogeneity at T4 and T8, respectively, compared with T0 (P<0.05). All other parameters represented on the graph improved after treatment with FRC but did not reach statistical significance.


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 improves vascular and pigmentary homogeneity. The mean values of the tested parameters were depicted using a “spider web” graph (Spiderming®). After 4 weeks of treatment (T4), 60% of subjects demonstrated an improvement of vascular homogeneity, while after 8 weeks of treatment (T8), a statistically significant improvement of pigmentary homogeneity was measured in 70% of the subjects (P<0.05 T0 versus T4 and T8).
© Copyright Policy
Related In: Results  -  Collection

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

f6-ccid-7-275: Farmaka Rosacea Cream improves vascular and pigmentary homogeneity. The mean values of the tested parameters were depicted using a “spider web” graph (Spiderming®). After 4 weeks of treatment (T4), 60% of subjects demonstrated an improvement of vascular homogeneity, while after 8 weeks of treatment (T8), a statistically significant improvement of pigmentary homogeneity was measured in 70% of the subjects (P<0.05 T0 versus T4 and T8).
Mentions: The “spider web” graph (Figure 6) revealed statistically significant improvements in vascular and pigmentary homogeneity at T4 and T8. Furthermore, 60% and 70% of the subjects demonstrated an improvement in pigmentary homogeneity at T4 and T8, respectively, compared with T0 (P<0.05). All other parameters represented on the graph improved after treatment with FRC but did not reach statistical significance.

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