154 SKIN CARE A B C D
Figure 2: Microscope images from skin samples treated with a control solution of niacinamide labelled with fluorescein (A), and skin samples treated with the bicomide system labelled with fluorescein (B, C and D).
Instrumental evaluation On the days of measurement, the volunteers participating in the study spent 10-20 minutes in a climate-controlled room: temperature 20ºC±2ºC and relative humidity 40%-60%. The measurements were performed at baseline (Day 0), after 15 days (Day 15) and 30 days after using the product (Day 30).
Assessment of sebum production Instrumental assessment of sebum excretion was measured on the face and forehead with Sebumeter SM 815 (Courage & Khazaka electronic). The measurement is based on grease spot photometry.
Prevention of acne development. Porphyrin percentage size area.
Instrumental assessment of the porphyrin % size area was carried out by taking photographs of the skin under UV light using Visiopor PP 34 (Courage & Khazaka electronic). The Visiopor PP 34 camera uses a specific UV-light to visualise the fluorescing acne lesions. The presence of porphyrins can be demonstrated by orange-red fluorescence in the follicle openings by examining the skin under appropriate UV-A light. The presences of porphyrins are directly related with the presence of P acnes.
Clinical evaluation Prevention of new acne lesions The dermatologist counted acne lesions before using the product and after 30 days of continuous use. The evaluated lesions were: closed comedones, open comedones, papules, pustules, cysts and nodules.
Visual evaluation of the volunteers Macrophotographs of each volunteer were taken with Visioface 1000D (Courage & Khazaka electronic) before using the product on Day 0 and on Day 30 in order to visualise the evolution of the lesions.
PERSONAL CARE EUROPE
Tolerance Dermatological and ophthalmological tolerance of the test product were performed following the score: 0: absence of effect, 1: very slight alteration, 2: slight alteration, 3: moderate alteration, 4: intense alteration. The parameters analysed by the dermatologist were: acne-prone skin, desquamation, dryness, redness, spots, oedema, vesicles/blisters; periocular inflammation. The parameters analysed by the ophthalmologist were: ocular redness, lacrimation burning, ocular dryness, itching, congestion, epiphora tendency and puffy eyelids.
Statistical studies Linear mixed-effect models (LMM) were fitted to evaluate the efficacy of the treatment over time (Day 0, Day 15 and Day 30). Generalised linear mixed-effect models (GLMM) were fitted to evaluate the efficacy of the treatment of the number of acneic alterations over time. The effect of the treatment on biometric measurements and the number of acneic alterations were interpreted using the reference of the baseline time (Day 0). The significance value established was 0.05 (95% confidence interval).
130 120 110 100 90 80 T0 T15 Time
Figure 3: Average sebum amount ± SE at different experimental days (0, 15 and 30) during the treatment with bicomide.
T30
Results and discussions Skin penetration studies Figure 2 shows four images of skin treated with the control and test product labelled with Sodium Fluorescein. The skin sample treated with the control (2A) shows the fluorescence, in green, on the surface of the skin. No penetration was observed in this skin sample indicating that the free fluorescent molecules were not able to penetrate the skin. However, when fluorescein was incorporated into bicomide fluorescence was observed in the stratum corneum and epidermis of flat skin areas and follicle (Figures 2B, 2C and 2D). This result indicates that bicosome structures were able to penetrate the skin and target the SC and epidermis areas. No alteration in the macrostructure of the skin was observed in the skin samples analysed, which indicates that the penetration promoted by the bicosome structures are gentle and do not cause disruption of skin structures.
In vivo studies: assessment of sebum excretion Figure 3 shows average values of sebum production evaluated in the volunteers at different times. After 15 days of continued use of the gel containing bicomide, a reduction of sebum of 13% in respect to baseline measurements was obtained. After 30 days, the amount of sebum had reduced by 25% (p <0.05). These results clearly show the synergic effects of delivering niacinamide with bicosomes. The retention in the epidermis and follicle probably potentiated the action of niacinamide, which presented higher efficacy with around 10x less concentration when compared with literature data.8
Prevention of acne lesions Figure 4 shows Visiopor images of three volunteers taken on Day 0 and Day 30 that illustrate that the reduction of fluorescence in the pores resulted from the reduction of porphyrins in the skin. The analyses of the images of the 20 volunteers show that the area covered by porphyrins (Fig 5)
April 2018
μg/cm2
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