SUMMARY
In the present double-blind study a compound containing natural polysaccharides derived from fish cartilage was compared with placebo. The treatment was given orally as two pills daily for three months. All subjects enrolled in the study had skin elastosis due to excessive exposure to natural sun light. The treatment groups included females aged 35 to 55 years.

Clinical evaluations were carried out at baseline and after one, two and three months of treatment. Two patients in the actively treated group and five patients in the placebo group were lost to follow-up. Almost 80% of the actively treated patients showed complete or almost complete cure after the treatment period as shown by clinical and photographical documentation. In addition, a significant improvement of fragile hair and brittleness of nails could be observed. In the placebo group no changes as compared with baseline could be observed after the treatment.

Because of geographical reasons the population in Italy is highly exposed to highly intense solar UV-light during long periods of the year. During the last decades tanning has become more popular, as tanned skin has become a status symbol. Especially females expose themselves to strong and damaging solar UV-light. Correctly used sun-screeners reduce the damages caused by UBV-light, but do not protect against UVA-light. Therefore sun-screeners do not prevent damage of collagen and elastic fibres in the dermis. This causes clinical changes such as thinning of the skin, laxity, solar keratosis, dyskeratosis and premalignant and malignant skin tumours. This condition, which is well documented, is called solar elastosis. As the mean age of the population steadily increases has also the incidence of elastosis increased, and there is now an urgent need to find means to prevent or decrease the severity of sun-damage of the skin.

During recent years several reports have confirmed that special marine derived substances seem to have a good effect as regards reconstruction of elastosis age-damaged skin (1,2,3). The present study was an evaluation of oral treatment of solar elastosis in females with Vivida.

PATIENTS AND METHODS
In a double-blind study 30 females with moderate to severe elastosis were enrolled to use either two tablets of Vivida or two tablets of placebo for a period of three months.

Before the start of the trial all subjects were orally informed about the nature of the study. At the baseline visit and monthly during the study a clinical evaluation of the severity of elastosis including wrinkles, thinning of the skin, laxity, dyskeratosis and eventual epitheliomas were recorded. After the end of the study the opinion regarding the effect of the treatment was also recorded.

At each visit a photograph was taken from the same site of the skin using a Skin-Polaphy, Marcor (100 x magnification).

RESULTS
During the treatment period two subjects treated with Vivida and five treated with placebo were lost to follow up. All 13 subjects in the Vivida group had a thicker and more elastic skin without dryness after the treatment. In ten cases (77%) fine wrinkles had completely or almost completely healed and in seven cases (54%) this was the case as regards deep wrinkles (> 1 mm). In the group treated with placebo no improvement of either thickness, elasticity, dryness or wrinkles could be observed by the investigators of the treated females. No adverse reactions were observed in either group during the treatment period.

DISCUSSION
A significant improvement of the skin structure and wrinkles could be observed in the group of females with sun-damaged skin treated with Vivida. No improvement was observed in the placebo group.

During discussions with the females who received active treatment it became definitely clear that all of them were highly satisfied with the result of the treatment and that all of them would have liked to be on the same treatment for a longer period of time. The females in the placebo group were very impressed by the results in the actively treated group and wished to receive the active Vivida tablets.

An important fact is that this new treatment against elastosis and wrinkles, e.g. by oral treatment, was found to be very comfortable as compared with topical or surgical treatment. It seems that oral treatment creates a higher enthusiasm and treatment compliance in the subjects treated with active Vivida pills, as the results were surprisingly good and better than expected by the investigators and treatment subjects. Even if the treatment period is rather long, this was not regarded as a negative point, as the treated females had earlier used anti-wrinkle creams for long periods without satisfying result.

In further studies we are planning to use ultrasound evaluations in order to get an objective picture of the effect on deeper skin structures.

1. Eskelinen A, Santalahti J: Special natural cartilage polysaccharides for the treatment of sun-damaged skin in females. J. Int. Med. Res. 1992;20:99 -105.
2. Eskelinen A, Santalahti J: Natural cartilage polysaccharides for the treatment of sun-damaged skin in females: A double-blind comparison of Vivida and Imedeen. J. Int. Med. Res. 1992;20:227 - 233.
3. Lassus A, Eskelinen A, Santalahti J: The effect of Vivida cream as compared with placebo cream in the treatment of sun-damaged or age-damaged facial skin. J. Int. Med. Res. 1992;20:381 - 391