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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

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f1-ccid-7-275: Study flow diagram.

Mentions: Forty-two of the 48 recruited subjects received treatment. In the short-term substudy, 20 subjects, with a mean age of 48 years (range 23–69 years), were treated. The long-term population comprised 22 subjects with rosacea (ten subjects [45%] subtype I; 12 subjects [55%] subtype II), with a mean age of 56 years (range 32–69 years). Half (50%) of the subjects in each substudy received treatment on the left side and half (50%) on the right side. In the long-term substudy, skin was classified as dry (eleven subjects [50%]), combination (six subjects [27%]), or normal (five subjects [23%]), with a skin phototype (Cesarini’s classification) of subtype II or IV (nine subjects each [41%]), subtype III (three subjects [13%]), or subtype V (one subject [5%]). Two subjects from the long-term population discontinued due to personal reasons unrelated to FRC. Thus, 20 subjects completed the long-term substudy (Figure 1).


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)

Study flow diagram.
© Copyright Policy
Related In: Results  -  Collection

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

f1-ccid-7-275: Study flow diagram.
Mentions: Forty-two of the 48 recruited subjects received treatment. In the short-term substudy, 20 subjects, with a mean age of 48 years (range 23–69 years), were treated. The long-term population comprised 22 subjects with rosacea (ten subjects [45%] subtype I; 12 subjects [55%] subtype II), with a mean age of 56 years (range 32–69 years). Half (50%) of the subjects in each substudy received treatment on the left side and half (50%) on the right side. In the long-term substudy, skin was classified as dry (eleven subjects [50%]), combination (six subjects [27%]), or normal (five subjects [23%]), with a skin phototype (Cesarini’s classification) of subtype II or IV (nine subjects each [41%]), subtype III (three subjects [13%]), or subtype V (one subject [5%]). Two subjects from the long-term population discontinued due to personal reasons unrelated to FRC. Thus, 20 subjects completed the long-term substudy (Figure 1).

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